HealthyPhase 1NCT02056600
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.
A Phase 1 study testing gemigliptin and metformin HCl extended release and gemigliptin/metformin HCl sustained release in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- gemigliptin and metformin HCl extended release and gemigliptin/metformin HCl sustained release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to May 2014
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults at age between 20 to 45 at the time of the screening
- ThoseSubjects whose BMI measurement at screening visit is between 18 and 27 kg/m2
- Subjects with fasting plasma glucose (FPG) of 70-125 mg/dL at screening visit
- Subject who has voluntarily decided to participate in this clinical trial and onsented in writing
Who cannot join
- Subjects who have a past or present clinically significant disease such as hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subjects who have a past history of gastrointestinal disease (e.g. Crohn's disease, ulcer, etc.) or surgery (however, simple appendectomy and hernioplasty are not included) that can affect the absorption of drugs
- Subjects with a medical history of allergic reaction to other drugs including the investigational products or clinically significant hypersensitivity reaction
- Subjects who have a history of drug abuse
- Subjects who have shown positive reaction to drugs that may be abused from a urine drug screening
- Subjects who took other investigational product in other trials within 90 days before the first administration of this investigational product
Show all 17Show fewer
- Subjects who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 30 days before the first administration
- Subjects who have taken a drug which is expected to have an effect on the clinical trial within 14 days before the date of the first administration of the investigational product or have had any food that is expected to have an effect on the clinical trial within 7 days (e.g. drinks containing caffeine, grapefruit juice, etc.)
- Subjects who have had alcohol containing drinks 3 times or more per week within one month before the screening visit or cannot abstain from drinking after completing the informed consent form for the participation in the study to the end of the clinical trial
- Subjects who have smoker more than 10 cigarettes per day within the recent one month at the screening visit or cannot refrain from smoking the clinical trial period
- In the vital signs measured in sitting position at the screening visit, subjects who have showed a systolic blood pressure of < 90 mmHg or > 145 mmHg, a diastolic blood pressure of > 95 mmHg or < 60 mmHg) , or a pulse rate of > 110 bpm or < 40 bpm
- Subjects who showed the following findings in the tests conducted during the screening period:
- In excess of 1.5 times the upper normal limit (UNL) in hepatic enzyme (AST and ALT) values
- The creatinine clearance calculated by Cockcroft-Gault equation is 80 mL/min or less
- Positive result in serum test (hepatitis type B test, hepatitis type C test, Human Immunodeficiency Virus (HIV) test, syphilis test)
- QTc > 450 msec in ECG or a clinically significant abnormal rhythm
- Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/1000mg in Comparison to Each Component Gemigliptin 50mg and Metformin HCl Extended Release 1000mg Administered in Healthy Male Volunteers
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl sustained release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemigliptin and metformin HCl extended releaseDrug
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
gemigliptin/metformin HCl sustained releaseDrug
Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.
| Study group | Role | What they receive |
|---|---|---|
| G+M | Experimental | Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg Receives: Drug: gemigliptin and metformin HCl extended release |
| C | Experimental | Combination of gemigliptin50mg/metformin HCl sustained release 1000mg Receives: Drug: gemigliptin/metformin HCl sustained release |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
To evaluate AUClast of gemigliptin and metformin
Measured: up to 48h post-dose
Cmax
To evaluate Cmax of gemigliptin and metformin
Measured: up to 48h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056600
- Sponsor's protocol ID
- LG-DMCL004
- Status last verified
- May 2014
- First submitted
- 5 Feb 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8.
PubMed 30288156
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/1000mg in Comparison to Each Component Gemigliptin 50mg and Metformin HCl Extended Release 1000mg Administered in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02056600
- Acronym / sponsor ID
- LG-DMCL004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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 to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G+M | Experimental | Drug: gemigliptin and metformin HCl extended releaseCoadministration of gemigliptin 50mg and metformin HCl extended release 1000mg |
| C | Experimental | Drug: gemigliptin/metformin HCl sustained releaseCombination of gemigliptin50mg/metformin HCl sustained release 1000mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults at age between 20 to 45 at the time of the screening
- ThoseSubjects whose BMI measurement at screening visit is between 18 and 27 kg/m2
- Subjects with fasting plasma glucose (FPG) of 70-125 mg/dL at screening visit
- Subject who has voluntarily decided to participate in this clinical trial and onsented in writing
Key exclusion criteria (17 listed)
- Subjects who have a past or present clinically significant disease such as hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subjects who have a past history of gastrointestinal disease (e.g. Crohn's disease, ulcer, etc.) or surgery (however, simple appendectomy and hernioplasty are not included) that can affect the absorption of drugs
- Subjects with a medical history of allergic reaction to other drugs including the investigational products or clinically significant hypersensitivity reaction
- Subjects who have a history of drug abuse
- Subjects who have shown positive reaction to drugs that may be abused from a urine drug screening
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 and metformin HCl extended releaseCoadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day | Drug | G+M |
| gemigliptin/metformin HCl sustained releaseAdministration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day. | Drug | C |
Primary outcome
AUClast
Time frame: up to 48h post-dose
To evaluate AUClast of gemigliptin and metformin
Cmax
Time frame: up to 48h post-dose
To evaluate Cmax of gemigliptin and metformin
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 8 May 2014.
- Derived from this study: PubMed 30288156Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8.
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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.
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 1 study testing gemigliptin and metformin HCl extended release and gemigliptin/metformin HCl sustained release in people with Healthy, run by LG Life Sciences 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 4 inclusion and 17 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 8 May 2014. 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?
AUClast (time frame: up to 48h 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?
On the ClinicalTrials.gov record for NCT02056600, which also lists 1 linked publication.
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 8 May 2014.