Type2 DiabetesPhase 1NCT04070794
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
A Phase 1 study testing Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) and Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) in people with Type2 Diabetes, run by LG Chem.
Trial summary
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) and Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 Dec 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.0 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- Female subjects abstain from either hormonal methods of contraception
- Male subjects who are willing or able to use effective contraceptive
- Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Who cannot join
- History serious hypersensitivity reactions
- History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
- History or evidence of family diabetes
- History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
- History or evidence of shock or severe dehydrate or severe infection such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period
- History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
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- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
- History of problems with swallowing tablet or capsule
- Difficulty fasting or consuming standardized meals
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition possibly affecting drug absorption
- Have renal creatinine clearance (Clcr) < 45 mL/min based on serum creatinine results at the screening laboratory test
- 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)
Read the detailed description
[Objectives] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions
[Admission and Confinement] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.
Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.
- Conditions
- Type2 Diabetes
- Being tested
- Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting), Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)Drug
Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.
Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)Drug
Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.
| Study group | Role | What they receive |
|---|---|---|
| FDC Zemimet® SR Tab. 50/1000(Fasting) | Active comparator | Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition Receives: Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) |
| FDC Zemimet® SR Tab. 50/1000(Fed) | Active comparator | Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition Receives: Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin
The observed maximum or peak concentration after administration of the drug
Measured: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
AUC0-tlast of gemigliptin, LC 15-0636 and metformin
Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured
Measured: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
AUC0-∞ of gemigliptin, LC 15-0636 and metformin
Area under the concentration-time curve from time zero to infinity by the extrapolation of the rest of AUC from last time where plasma concentration can be measured to time infinity
Measured: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 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 posted28 Aug 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uthai Suvanakoot, Principal investigator, International Bio Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070794
- Sponsor's protocol ID
- LG-DMCL008
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04070794
- Acronym / sponsor ID
- LG-DMCL008
- Conditions
- Type2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 28 Aug 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.
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)
Detailed description
[Objectives] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions
[Admission and Confinement] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.
Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDC Zemimet® SR Tab. 50/1000(Fasting) | Active comparator | Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition |
| FDC Zemimet® SR Tab. 50/1000(Fed) | Active comparator | Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index between 18.0 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- Female subjects abstain from either hormonal methods of contraception
- Male subjects who are willing or able to use effective contraceptive
Key exclusion criteria (13 listed)
- History serious hypersensitivity reactions
- History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
- History or evidence of family diabetes
- History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
- History or evidence of shock or severe dehydrate or severe infection such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period
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 |
|---|---|---|
| Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours. | Drug | FDC Zemimet® SR Tab. 50/1000(Fasting) |
| Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast. | Drug | FDC Zemimet® SR Tab. 50/1000(Fed) |
Primary outcome
Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin
Time frame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
The observed maximum or peak concentration after administration of the drug
AUC0-tlast of gemigliptin, LC 15-0636 and metformin
Time frame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured
AUC0-∞ of gemigliptin, LC 15-0636 and metformin
Time frame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.
Area under the concentration-time curve from time zero to infinity by the extrapolation of the rest of AUC from last time where plasma concentration can be measured to time infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- 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.
Uthai Suvanakoot principal investigator
International Bio Service Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) and Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) in people with Type2 Diabetes, run by LG Chem.
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 13 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 28 Aug 2019. 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 Eunjoo Cho (+82-2-6987-4284, eunjoo.cho@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin (time frame: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.). The study lists 3 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 28 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.