HealthyPhase 1NCT01825850
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
A Phase 1 study testing Gemigliptin and Irbesartan in people with Healthy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects. 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 Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Mar 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
- Age between 20 to 45, healthy male subjects (at screening)
- BMI between 18 - 27 kg/m2 (at screening)
- Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- 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 that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
- Subject who already admitted in other investigator product in 80 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 Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects
The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.
- Conditions
- Healthy
- Being tested
- Gemigliptin, Irbesartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemigliptinDrug
IrbesartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin | Experimental | Gemigliptin 50mg q.d. during 7 days Receives: Drug: Gemigliptin |
| Irbesartan | Experimental | Irbesartan 300mg q.d. during 7 days Receives: Drug: Irbesartan |
| Gemiglitin + Irbesartan | Experimental | Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days Receives: Drug: Gemigliptin; Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
To evaluate Cmax,ss of Gemigliptin and Irbesartan
Measured: up to 72h post-dose
AUCτ,ss
To evaluate AUCτ,ss of Gemigliptin and Irbesartan
Measured: up to 72h post-dose
Secondary outcomes (5)
Cmin,ss
To evaluate Cmin,ss of Gemigliptin and Irbesartan
Measured: up to 72h post-dose
Tmax,ss
To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)
Measured: up to 72h post-dose
Cmax,ss
To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)
Measured: up to 72h post-dose
AUCτ,ss
To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)
Measured: up to 72h post-dose
metabolic ratio
To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)
Measured: up to 72h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionMar 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
- 30 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
- NCT01825850
- Sponsor's protocol ID
- LG-GBCL001
- Status last verified
- Dec 2014
- First submitted
- 3 Apr 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
PubMed 25350224
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. 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 Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01825850
- Acronym / sponsor ID
- LG-GBCL001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Apr 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 is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin | Experimental | Drug: GemigliptinGemigliptin 50mg q.d. during 7 days |
| Irbesartan | Experimental | Drug: IrbesartanIrbesartan 300mg q.d. during 7 days |
| Gemiglitin + Irbesartan | Experimental | Drug: Gemigliptin, Drug: IrbesartanGemigliptin 50mg + Irbesartan 300mg q.d. during 7 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (5 listed)
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 | Drug | Gemigliptin, Gemiglitin + Irbesartan |
| Irbesartan | Drug | Gemiglitin + Irbesartan, Irbesartan |
Primary outcome
Cmax,ss
Time frame: up to 72h post-dose
To evaluate Cmax,ss of Gemigliptin and Irbesartan
AUCτ,ss
Time frame: up to 72h post-dose
To evaluate AUCτ,ss of Gemigliptin and Irbesartan
5 secondary outcomes
Cmin,ss
Time frame: up to 72h post-dose
Tmax,ss
Time frame: up to 72h post-dose
Cmax,ss
Time frame: up to 72h post-dose
AUCτ,ss
Time frame: up to 72h post-dose
metabolic ratio
Time frame: up to 72h 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 30 Dec 2014.
- Derived from this study: PubMed 25350224Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
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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 Irbesartan 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 5 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 30 Dec 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?
Cmax,ss (time frame: up to 72h 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 NCT01825850, 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 30 Dec 2014.