Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Gemigliptin; Drug: Irbesartan

• Registration Number: NCT01825850
• Lead Sponsor: LG Life Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Study Start: 2013-06
• Primary Completion: 2013-09
• Study Completion: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gemigliptin	Gemigliptin	Gemigliptin 50mg q.d. during 7 days
Irbesartan	Irbesartan	Irbesartan 300mg q.d. during 7 days
Gemiglitin + Irbesartan	Irbesartan	Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days
Gemiglitin + Irbesartan	Gemigliptin	Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days

Primary Outcome Measures

Name	Time	Method
Cmax,ss	up to 72h post-dose	To evaluate Cmax,ss of Gemigliptin and Irbesartan
AUCτ,ss	up to 72h post-dose	To evaluate AUCτ,ss of Gemigliptin and Irbesartan

Secondary Outcome Measures

Name	Time	Method
Cmin,ss	up to 72h post-dose	To evaluate Cmin,ss of Gemigliptin and Irbesartan
Tmax,ss	up to 72h post-dose	To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)
Cmax,ss	up to 72h post-dose	To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)
AUCτ,ss	up to 72h post-dose	To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)
metabolic ratio	up to 72h post-dose	To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of