HealthyPhase 1NCT01662674
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 extended 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/pharmacodynamics 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 extended release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Mar 2013
- 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
- Age between 20 to 45, healthy male subjects(at screening)
- Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- FPG 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Who cannot join
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- Subject who already participated in other trials in 3months
- Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
- Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics 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 extended 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 extended releaseDrug
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, 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 extended release 1000mg Receives: Drug: gemigliptin/metformin HCl extended 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
Secondary outcomes (1)
AUEC
This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.
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 posted10 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionMar 2013
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT01662674
- Sponsor's protocol ID
- LG-DMCL002
- Status last verified
- Apr 2015
- First submitted
- 6 Aug 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015.
PubMed 25678778
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01662674
- Acronym / sponsor ID
- LG-DMCL002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Aug 2012 (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/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- 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 extended releaseCombination of gemigliptin50mg/metformin HCl extended release 1000mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 to 45, healthy male subjects(at screening)
- Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- FPG 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Key exclusion criteria (6 listed)
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- Subject who already participated in other trials in 3months
- Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
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 extended releaseAdministration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, 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
1 secondary outcome
AUEC
Time frame: up to 48h 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 3 Apr 2015.
- Derived from this study: PubMed 25678778Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015.
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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 extended 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 6 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 3 Apr 2015. 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 NCT01662674, 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 3 Apr 2015.