Healthy VollunteerPhase 1NCT06308679
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions
A Phase 1 study testing Empagliflozin 10 mg tablets and JARDIANCE® in people with Healthy Vollunteer, run by Pharma Nueva.
Trial summary
Objectives: Primary: to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditions Secondary: To examine the pharmacokinetics and safety of test and reference… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Vollunteer
- What is being tested?
- Empagliflozin 10 mg tablets and JARDIANCE®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2024to 7 Jun 2024
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thai male and/or female age between 18-55 years
- Has body mass index (BMI) between 18.0-30.0 kg/m2
- Has been determined healthy by physical examination, assessment of medical history, and vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 139 mmHg, diastolic blood pressure not lower than 60 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians
- Has normal or acceptable results (being assessed as not clinically significant by the clinical investigator) for all screening tests including: Complete Blood Count (CBC), Fasting Blood Sugar (FBS), Aspartate Aminotransferase (AST or SGOT), Alanine Aminotransferase (ALT or SGPT), Alkaline Phosphatase (ALP), Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine (Cr), Potassium, Sodium, Chloride, Phosphate and Urinalysis
- Has negative result for Hepatitis B viral profile (HBsAg)
- Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG
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- Male subjects agree to use effective contraceptive from screening visit to the follow-up visit.
- Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing at screening and prior to dosing at period 1 and period 2.
- Female subjects who is childbearing potential and using effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) or total abstinence from sexual intercourse from screening visit to the follow-up visit.
- Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)).
- Non-smokers (never smoked or no smoking within the previous 1 year)
- Refrain from using herbal medications, cannabis containing products, dietary supplements (e.g., St. John's Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2.
- Subjects must have ended the systematic medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period.
- Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 2.
- Has ability and intention to comply with the requirement of study and available for the whole study period
- Willing to participate and voluntarily signed the informed consent form prior to participate the study
Who cannot join
- Known hypersensitivity to empagliflozin and/or related structure and/or its constituents.
- Has history or concurrent symptoms of cardiovascular, gastrointestinal, hematological disorders, renal and hepatic impairment and/or any disease that may affect the bioavailability of the drug.
- Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months
- Alcohol breath test at screening visit or before admission show alcohol concentration more than 0.000 %BAC.
- History of drug abuse or urine sample shows a positive test for Morphine, Tetrahydrocannabinol and Methamphetamine at screening visit or before admission.
- Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
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- A pregnant woman (positive pregnancy test at screening or prior to dosing in each period) or woman in breast feeding period
- A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to dosing and during the entire period of the study and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to dosing and during the entire period of the study
- A participant in any investigation drug study within last 30 days prior to screening (from the last visit that received medication to the screening visit)
- Has blood donated within last 2 months
Trial locations and contacts
No sites are listed yet.
About this study
Objectives:
Primary:
to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditions
Secondary:
To examine the pharmacokinetics and safety of test and reference formulations
Study Design:
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions
Read the detailed description
Subjects will be fasted at least 10 hours before dosing. After that a single dose of 10-mg Empagliflozin tablets will be administered along with 240 mL of drinking water under fasting condition. In each period, a total of 21 blood samples (approximately 6 mL each) from 21 sampling time points will be collected at pre-dose (6-mL tubes) and at 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 36.00 and 48.00 h post dose. Blood glucose level will be measured at approximately pre-dose, 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00 hours post-dose in each period for subject's safety. During blood sample collection, one drop of blood will be used for this test.
- Conditions
- Healthy Vollunteer
- Being tested
- Empagliflozin 10 mg tablets, JARDIANCE®
- Keywords
- Empagliflozin, Bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 mg tabletsDrug
Empagliflozin 10 mg tablets (test drug)
JARDIANCE®Drug
Also called Empagliflozin 10 mg tablets
Empagliflozin 10 mg tablets (reference drug)
| Study group | Role | What they receive |
|---|---|---|
| Generic Empagliflozin 10 mg tablets | Experimental | Generic Empagliflozin 10 mg tablets (test drug) Receives: Drug: Empagliflozin 10 mg tablets; Drug: JARDIANCE® |
| ARDIANCE® | Active comparator | ARDIANCE® (Empagliflozin 10 mg tablets (reference drug)) Receives: Drug: Empagliflozin 10 mg tablets; Drug: JARDIANCE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
Measured: Through 48 hours post dose
Peak Plasma Concentration (Cmax) of Empagliflozin
Peak Plasma Concentration (Cmax) of Empagliflozin
Measured: 48 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 posted13 Mar 2024
- Study start28 May 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VollunteerStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharma Nueva
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308679
- Sponsor's protocol ID
- BE 001-24
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06308679
- Acronym / sponsor ID
- BE 001-24
- Conditions
- Healthy Vollunteer
- Keywords
- Empagliflozin, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Pharma NuevaIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
Objectives:
Primary:
to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditions
Secondary:
To examine the pharmacokinetics and safety of test and reference formulations
Study Design:
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions
Detailed description
Subjects will be fasted at least 10 hours before dosing. After that a single dose of 10-mg Empagliflozin tablets will be administered along with 240 mL of drinking water under fasting condition. In each period, a total of 21 blood samples (approximately 6 mL each) from 21 sampling time points will be collected at pre-dose (6-mL tubes) and at 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 36.00 and 48.00 h post dose. Blood glucose level will be measured at approximately pre-dose, 0.33, 0.67, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00 hours post-dose in each period for subject's safety. During blood sample collection, one drop of blood will be used for this test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Empagliflozin 10 mg tablets | Experimental | Drug: Empagliflozin 10 mg tablets, Drug: JARDIANCE®Generic Empagliflozin 10 mg tablets (test drug) |
| ARDIANCE® | Active comparator | Drug: Empagliflozin 10 mg tablets, Drug: JARDIANCE®ARDIANCE® (Empagliflozin 10 mg tablets (reference drug)) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Thai male and/or female age between 18-55 years
- Has body mass index (BMI) between 18.0-30.0 kg/m2
- Has been determined healthy by physical examination, assessment of medical history, and vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 139 mmHg, diastolic blood pressure not lower than 60 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians
- Has normal or acceptable results (being assessed as not clinically significant by the clinical investigator) for all screening tests including: Complete Blood Count (CBC), Fasting Blood Sugar (FBS), Aspartate Aminotransferase (AST or SGOT), Alanine Aminotransferase (ALT or SGPT), Alkaline Phosphatase (ALP), Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine (Cr), Potassium, Sodium, Chloride, Phosphate and Urinalysis
- Has negative result for Hepatitis B viral profile (HBsAg)
Key exclusion criteria (10 listed)
- Known hypersensitivity to empagliflozin and/or related structure and/or its constituents.
- Has history or concurrent symptoms of cardiovascular, gastrointestinal, hematological disorders, renal and hepatic impairment and/or any disease that may affect the bioavailability of the drug.
- Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months
- Alcohol breath test at screening visit or before admission show alcohol concentration more than 0.000 %BAC.
- History of drug abuse or urine sample shows a positive test for Morphine, Tetrahydrocannabinol and Methamphetamine at screening visit or before admission.
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 |
|---|---|---|
| Empagliflozin 10 mg tabletsEmpagliflozin 10 mg tablets (test drug) | Drug | ARDIANCE®, Generic Empagliflozin 10 mg tablets |
| JARDIANCE®Also: Empagliflozin 10 mg tabletsEmpagliflozin 10 mg tablets (reference drug) | Drug | ARDIANCE®, Generic Empagliflozin 10 mg tablets |
Primary outcome
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
Time frame: Through 48 hours post dose
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin
Peak Plasma Concentration (Cmax) of Empagliflozin
Time frame: 48 hours post dose
Peak Plasma Concentration (Cmax) of Empagliflozin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No. Confidential
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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.
Porranee Puranajoti principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empagliflozin 10 mg tablets and JARDIANCE® in people with Healthy Vollunteer, run by Pharma Nueva.
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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aksorn Jarupintusopon (0918744146, aksorn.riengsilchai@pharmanueva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin (time frame: Through 48 hours post dose). The study lists 2 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 13 Mar 2024.