PharmacokineticsPhase 2/3NCT07560150
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
A Phase 2/3 study testing I004 and NovoLog in people with Pharmacokinetics and Pharmacodynamics, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Pharmacodynamics, Insulin Aspart
- What is being tested?
- I004 and NovoLog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to 25 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upon review, agree to participate and sign informed consent.
- Healthy male and female subjects ≥ 18 to ≤ 65 years of age.
- Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2
- Weight ≥ 50 kg.
- Fasting plasma glucose of < 100 mg/dL (5.5 mmol/L) measured with YSI at site; one repeat test is allowed.
- HbA1c < 5.7%.
- Non-smoker for ≥ 3 months prior to Screening.
- Female candidates must be > 1 year post-menopausal, surgically sterile, or practicing a clinically acceptable form of birth control and confirmed by negative serum pregnancy test at Screening.
Who cannot join
- History of diabetes mellitus.
- Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
- Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
- History of any serious adverse reaction or hypersensitivity to any of the investigational product components.
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
- Subject shows evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant/anti-anxiety medication).
Show all 21Show fewer
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject (laboratory results may be re-checked once on a separate day per Investigator discretion).
- Long QT syndrome or family history of long QT syndrome or corrected QT interval (QTcF) > 450 ms in men, > 470 ms in women at Screening.
- Liver function test results of AST and/or ALT ≥ 2.5 upper normal limit (ULN)
- Subject has a history of syncope.
- History of any major surgery within 6 months.
- History of any active infection, other than mild viral illness within 30 days prior to dosing.
- History of blood clots (e.g., deep vein thrombosis or embolism) or a frequent appearance in 1st degree relatives as judged by the Investigator.
- Known history or positive test of hepatitis B surface antigen (HBsAG), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
- History of systemic glucocorticoid use within 3 months before screening.
- History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week (males) and > 14 units/week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU). Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL of spirits).
- History of illicit drug abuse, including marijuana, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test at Screening.
- Donation or loss of > 500 mL of blood within 56 days.
- Chronic use of over-the-counter or prescription medication within 7 or 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods [Desogestrel is not allowed]).
- Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.
- Women who are pregnant of breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
- Conditions
- Pharmacokinetics, Pharmacodynamics, Insulin Aspart
- Being tested
- I004, NovoLog
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I004Drug
Also called Insulin Aspart, a rapid-acting human insulin analogue
Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.
NovoLogDrug
Also called Insulin Aspart, a rapid-acting human insulin analogue
Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Aspart, I004 | Experimental | Participants who were dosed with I004 Receives: Drug: I004 |
| NovoLog | Active comparator | Participants who were dosed with NovoLog Receives: Drug: NovoLog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Serum Insulin Aspart Concentration, CIAmax
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart
Measured: Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h)
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCIA(0-12h)) is reported.
Measured: 0 to 12 hours post-dose
Maximum Glucose Infusion Rate, Gmax
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
Measured: From drug administration to 12 hours post-dose
Secondary outcomes (19)
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-∞) will be calculated from the concentration curves. AUCIA(0-∞) is derived using standard extrapolation beyond the last measurable concentration.
Measured: 0 to infinity (extrapolated; concentrations measured through 12 hours post-dose)
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 2 Hours Post-dose, AUCIA(0-2h)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-2h) will be calculated from the concentration curves. Only AUC from 0 to 2 hours (AUCIA(0-2h)) is reported.
Measured: 0 to 2 hours post-dose
Time of Maximum Insulin Aspart Serum Concentration, tIAmax
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart.
Measured: Baseline (Time 0) to 12 hours post-dose
Apparent Clearance of Insulin Aspart (CL/F)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart.
Measured: Baseline (Time 0) to 12 hours post-dose
Apparent Volume of Distribution of Insulin Aspart (Vz/F)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart.
Measured: Baseline (Time 0) to 12 hours post-dose
Half-life of Insulin Aspart (t1/2)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart.
Measured: Baseline (Time 0) to 12 hours post-dose
Maximum Serum Human Insulin Concentration, CHImax
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin.
Measured: Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) of Human Insulin Serum Concentration From Time 0 to 12 hours post-dose, AUCHI(0-12h)
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin. AUCHI(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCHI(0-12h)) is reported.
Measured: Baseline (Time 0) to 12 hours post-dose
Time of Maximum Human Insulin Serum Concentration, tHImax
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin.
Measured: Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate Due to Insulin Aspart From Time 0 to 12 Hours Post-dose, AUCGA(0-12h)
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCGA(0-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
Measured: From drug administration to 12 hours post-dose
Maximum Glucose Infusion Rate Due to Insulin Aspart, GAmax
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) From Time 0 to the Time of Last Measurable GIR, AUCG(0-last)
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-last) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
Measured: From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 2 Hours Post-dose, AUCG(0-2h)
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-2h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
Measured: From drug administration to 2 hours post-dose
Last Measurable Glucose Infusion Rate (Glast)
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Time of Maximum Glucose Infusion Rate, tGmax
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Time of Glucose Infusion Start, tGonset
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Time of Last Measurable Glucose Infusion Rate, tGlast
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%early
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%late
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Measured: From drug administration to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start6 Apr 2026
- Primary completion22 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560150
- Sponsor's protocol ID
- API-I004-CL-C
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Access to patient level data and supporting clinical documents may be requested by qualified researchers. Requests will be reviewed on the basis of scientific merit. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study
- ClinicalTrials.gov ID
- NCT07560150
- Acronym / sponsor ID
- API-I004-CL-C
- Conditions
- Pharmacokinetics, Pharmacodynamics, Insulin Aspart
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Aspart, I004 | Experimental | Drug: I004Participants who were dosed with I004 |
| NovoLog | Active comparator | Drug: NovoLogParticipants who were dosed with NovoLog |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Upon review, agree to participate and sign informed consent.
- Healthy male and female subjects ≥ 18 to ≤ 65 years of age.
- Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2
- Weight ≥ 50 kg.
- Fasting plasma glucose of < 100 mg/dL (5.5 mmol/L) measured with YSI at site; one repeat test is allowed.
Key exclusion criteria (21 listed)
- History of diabetes mellitus.
- Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
- Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
- History of any serious adverse reaction or hypersensitivity to any of the investigational product components.
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I004Also: Insulin Aspart, a rapid-acting human insulin analogueDrug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition. | Drug | Insulin Aspart, I004 |
| NovoLogAlso: Insulin Aspart, a rapid-acting human insulin analogueDrug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition. | Drug | NovoLog |
Primary outcome
Maximum Serum Insulin Aspart Concentration, CIAmax
Time frame: Baseline (Time 0) to 12 hours post-dose
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h)
Time frame: 0 to 12 hours post-dose
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCIA(0-12h)) is reported.
Maximum Glucose Infusion Rate, Gmax
Time frame: From drug administration to 12 hours post-dose
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)
Time frame: From drug administration to 12 hours post-dose
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.
19 secondary outcomes
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞)
Time frame: 0 to infinity (extrapolated; concentrations measured through 12 hours post-dose)
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 2 Hours Post-dose, AUCIA(0-2h)
Time frame: 0 to 2 hours post-dose
Time of Maximum Insulin Aspart Serum Concentration, tIAmax
Time frame: Baseline (Time 0) to 12 hours post-dose
Apparent Clearance of Insulin Aspart (CL/F)
Time frame: Baseline (Time 0) to 12 hours post-dose
Apparent Volume of Distribution of Insulin Aspart (Vz/F)
Time frame: Baseline (Time 0) to 12 hours post-dose
Half-life of Insulin Aspart (t1/2)
Time frame: Baseline (Time 0) to 12 hours post-dose
Maximum Serum Human Insulin Concentration, CHImax
Time frame: Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) of Human Insulin Serum Concentration From Time 0 to 12 hours post-dose, AUCHI(0-12h)
Time frame: Baseline (Time 0) to 12 hours post-dose
Time of Maximum Human Insulin Serum Concentration, tHImax
Time frame: Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate Due to Insulin Aspart From Time 0 to 12 Hours Post-dose, AUCGA(0-12h)
Time frame: From drug administration to 12 hours post-dose
Maximum Glucose Infusion Rate Due to Insulin Aspart, GAmax
Time frame: From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) From Time 0 to the Time of Last Measurable GIR, AUCG(0-last)
Time frame: From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 2 Hours Post-dose, AUCG(0-2h)
Time frame: From drug administration to 2 hours post-dose
Last Measurable Glucose Infusion Rate (Glast)
Time frame: From drug administration to 12 hours post-dose
Time of Maximum Glucose Infusion Rate, tGmax
Time frame: From drug administration to 12 hours post-dose
Time of Glucose Infusion Start, tGonset
Time frame: From drug administration to 12 hours post-dose
Time of Last Measurable Glucose Infusion Rate, tGlast
Time frame: From drug administration to 12 hours post-dose
Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%early
Time frame: From drug administration to 12 hours post-dose
Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%late
Time frame: From drug administration to 12 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided. Access to patient level data and supporting clinical documents may be requested by qualified researchers. Requests will be reviewed on the basis of scientific merit. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing I004 and NovoLog in people with Pharmacokinetics and Pharmacodynamics, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Serum Insulin Aspart Concentration, CIAmax (time frame: Baseline (Time 0) to 12 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.