HealthyPhase 1NCT03927170
Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed)
A Phase 1 study testing Janumet XR tablet 100/1000 mg and GLH1SM tablet 100/1000 mg in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial summary
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Janumet XR tablet 100/1000 mg and GLH1SM tablet 100/1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2019to 23 Oct 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects who, at the time of screening, are the age of older than 19 years
- Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
- There is no congenital disease or within 3 years of chronic diseases
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests
- Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
- History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
- A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
- A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
Show all 20Show fewer
- A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
- A smoker who consumes more than 20 cigarettes/day within 6 months
- A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
- A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
- Acute effects that may affect renal function in patients with moderate and severe renal failure (eGFR<45 mL/min/1.73m2) such as sepsis, dehydration, severe infection, cardiovascular collapse, acute myocardial infarction
- Acute and unstable heart failure
- Patients receiving intravenous administration of radiation iodine contrast media (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.)
- Patients who are known to be hypersensitive to anaphylaxis or angioedema for the drug or its components
- Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- Patients with severe infectious disease or severe traumatic systemic disorder
- Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs
- Pregnant women, women who may be pregnant, breastfeeding
- A subject who is not eligible for the study due to reasons on the investigators' judgement
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition
Read the detailed description
2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet
- Conditions
- Healthy
- Being tested
- Janumet XR tablet 100/1000 mg, GLH1SM tablet 100/1000 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janumet XR tablet 100/1000 mgCombination product
Also called Sitagliptin and Metformin in Fixed Dose Combination
To administrate the Janumet XR tablet
GLH1SM tablet 100/1000 mgCombination product
Also called Sitagliptin and Metformin in Fixed Dose Combination
To administrate the GLH1SM tablet
| Study group | Role | What they receive |
|---|---|---|
| GLH1SM tablet 100/1000 mg in FDC | Experimental | GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration Receives: Combination Product: GLH1SM tablet 100/1000 mg |
| Janumet XR tablet 100/1000 mg in FDC | Active comparator | Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration Receives: Combination Product: Janumet XR tablet 100/1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt in ng·h/mL
Metformin
Measured: 24 hours
Cmax in ng/mL
Metformin
Measured: 24 hours
Secondary outcomes (5)
AUCinf in ng·h/mL
Metformin
Measured: 24 hours
Tmax in hour
Metformin
Measured: 24 hours
t1/2 in hour
Metformin
Measured: 24 hours
CL/F in Liter/min/kg
Metformin
Measured: 24 hours
Vd/F in Liter/kg
Metformin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start2 May 2019
- Primary completion11 Sep 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungho Jang, MD, Ph.D, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927170
- Sponsor's protocol ID
- GLH1SM-102
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03927170
- Acronym / sponsor ID
- GLH1SM-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 25 Apr 2019 (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.
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition
Detailed description
2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLH1SM tablet 100/1000 mg in FDC | Experimental | Combination Product: GLH1SM tablet 100/1000 mgGLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration |
| Janumet XR tablet 100/1000 mg in FDC | Active comparator | Combination Product: Janumet XR tablet 100/1000 mgJanumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male subjects who, at the time of screening, are the age of older than 19 years
- Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
- There is no congenital disease or within 3 years of chronic diseases
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests
- Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
Key exclusion criteria (20 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
- History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
- A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
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 |
|---|---|---|
| Janumet XR tablet 100/1000 mgAlso: Sitagliptin and Metformin in Fixed Dose CombinationTo administrate the Janumet XR tablet | Combination product | Janumet XR tablet 100/1000 mg in FDC |
| GLH1SM tablet 100/1000 mgAlso: Sitagliptin and Metformin in Fixed Dose CombinationTo administrate the GLH1SM tablet | Combination product | GLH1SM tablet 100/1000 mg in FDC |
Primary outcome
AUCt in ng·h/mL
Time frame: 24 hours
Metformin
Cmax in ng/mL
Time frame: 24 hours
Metformin
5 secondary outcomes
AUCinf in ng·h/mL
Time frame: 24 hours
Tmax in hour
Time frame: 24 hours
t1/2 in hour
Time frame: 24 hours
CL/F in Liter/min/kg
Time frame: 24 hours
Vd/F in Liter/kg
Time frame: 24 hours
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Kyungho Jang, MD, Ph.D principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Janumet XR tablet 100/1000 mg and GLH1SM tablet 100/1000 mg in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
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 6 inclusion and 20 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 23 Jul 2020. 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 South Korea. 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 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?
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?
AUCt in ng·h/mL (time frame: 24 hours). 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 23 Jul 2020.