HealthyPhase 1NCT02670018
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg 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
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 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release… Read more about this study
- Who is it for?
- Ages 19 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
- 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
- Aug 2015to Mar 2016
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 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, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers
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 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) 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 * 2 tablets, for 1 day
gemigliptin/metformin HCl extended releaseDrug
Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day
| Study group | Role | What they receive |
|---|---|---|
| G+M | Active comparator | Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets Receives: Drug: gemigliptin and metformin HCl extended release |
| C | Experimental | Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets 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 (13)
Tmax of Gemigliptin, Metformin
Measured: up to 48h post-dose
AUCinf of Gemigliptin, Metformin
Measured: up to 48h post-dose
t1/2 of Gemigliptin, Metformin
Measured: up to 48h post-dose
CL/F of Gemigliptin, Metformin
Measured: up to 48h post-dose
Vd/F of Gemigliptin, Metformin
Measured: up to 48h post-dose
AUC0-48h of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
Cmax of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
Tmax of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
AUCinf of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
t1/2 of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
CL/F of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
Vd/F of Gemigliptin metabolite(LC15-0636)
Measured: up to 48h post-dose
metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)
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 posted1 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionMar 2016 (estimated)
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
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670018
- Sponsor's protocol ID
- LG-DMCL005
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. 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 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02670018
- Acronym / sponsor ID
- LG-DMCL005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 1 Feb 2016 (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.
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 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) 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 | Active comparator | Drug: gemigliptin and metformin HCl extended releaseCoadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets |
| C | Experimental | Drug: gemigliptin/metformin HCl extended releaseCombination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 19 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 * 2 tablets, for 1 day | Drug | G+M |
| gemigliptin/metformin HCl extended releaseAdministration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, 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
13 secondary outcomes
Tmax of Gemigliptin, Metformin
Time frame: up to 48h post-dose
AUCinf of Gemigliptin, Metformin
Time frame: up to 48h post-dose
t1/2 of Gemigliptin, Metformin
Time frame: up to 48h post-dose
CL/F of Gemigliptin, Metformin
Time frame: up to 48h post-dose
Vd/F of Gemigliptin, Metformin
Time frame: up to 48h post-dose
AUC0-48h of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
Cmax of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
Tmax of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
AUCinf of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
t1/2 of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
CL/F of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
Vd/F of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)
Time frame: up to 48h post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- 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.
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: status not confirmed, as of the sponsor's last update on 2 Feb 2016. 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?
Results are not available in the source record.
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?
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 2 Feb 2016.