HealthyPhase 1NCT01768455
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects
A Phase 1 study testing Gemigliptin and Glimepiride and Glimepiride in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone. 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 Glimepiride and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Apr 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)
- BMI between 18 - 27 (at screening)
- 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
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.(gemigliptin, glimepiride, aspirin, antibiotics)
- Subject who already participated in other trials in 90 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects
The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.
- Conditions
- Healthy
- Being tested
- Gemigliptin and Glimepiride, Glimepiride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemigliptin and GlimepirideDrug
Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7
GlimepirideDrug
Glimepiride 4mg (qd) on Day1
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin and Glimepiride | Experimental | Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride Receives: Drug: Gemigliptin and Glimepiride |
| Glimepiride | Experimental | Single administration of glimepiride Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride
Measured: up to 24h post-dose
Cmax
To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride
Measured: up to 24h post-dose
Secondary outcomes (4)
Tmax
To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1
Measured: up to 24h post-dose
t1/2β
To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1
Measured: up to 24h post-dose
AUC
To evaluate AUCτ,ss of LC15-0636 and AUClast of M1
Measured: up to 24h post-dose
Cmax
To evaluate Cmax,ss of LC15-0636 and Cmax of M1
Measured: up to 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768455
- Sponsor's protocol ID
- LG-DPCL013
- Status last verified
- Apr 2013
- First submitted
- 13 Jan 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01768455
- Acronym / sponsor ID
- LG-DPCL013
- 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
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- First posted
- 15 Jan 2013 (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.
The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin and Glimepiride | Experimental | Drug: Gemigliptin and GlimepirideMultiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride |
| Glimepiride | Experimental | Drug: GlimepirideSingle administration of glimepiride |
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)
- BMI between 18 - 27 (at screening)
- 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
Key exclusion criteria (5 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.(gemigliptin, glimepiride, aspirin, antibiotics)
- Subject who already participated in other trials in 90 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days 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 GlimepirideGemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7 | Drug | Gemigliptin and Glimepiride |
| GlimepirideGlimepiride 4mg (qd) on Day1 | Drug | Glimepiride |
Primary outcome
AUC
Time frame: up to 24h post-dose
To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride
Cmax
Time frame: up to 24h post-dose
To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride
4 secondary outcomes
Tmax
Time frame: up to 24h post-dose
t1/2β
Time frame: up to 24h post-dose
AUC
Time frame: up to 24h post-dose
Cmax
Time frame: up to 24h 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 23 Apr 2013.
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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.
Kyun-Seop Bae, M.D., Ph.D. principal investigator
Asan Medical Center
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 Glimepiride and Glimepiride 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 5 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 Apr 2013. 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?
AUC (time frame: up to 24h 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 23 Apr 2013.