Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Gemigliptin and Glimepiride; Drug: Glimepiride

• Registration Number: NCT01768455
• Lead Sponsor: LG Life Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Study Start: 2013-02
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gemigliptin and Glimepiride	Gemigliptin and Glimepiride	Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride
Glimepiride	Glimepiride	Single administration of glimepiride

Primary Outcome Measures

Name	Time	Method
AUC	up to 24h post-dose	To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride
Cmax	up to 24h post-dose	To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride

Secondary Outcome Measures

Name	Time	Method
AUC	up to 24h post-dose	To evaluate AUCτ,ss of LC15-0636 and AUClast of M1
Cmax	up to 24h post-dose	To evaluate Cmax,ss of LC15-0636 and Cmax of M1
Tmax	up to 24h post-dose	To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1
t1/2β	up to 24h post-dose	To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1

Trial Locations

Locations (1)

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