BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

Phase 1

• Conditions: Healthy
• Interventions: Drug: gemigliptin 50mg, rosuvastatin 20mg

• Registration Number: NCT02670070
• Lead Sponsor: LG Life Sciences

Brief Summary

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Detailed Description

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Study Timeline

• Study First Submitted: 2015-12-22
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2016-03
• Primary Completion: 2016-04
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

• Age between 19 to 45, healthy male subjects(at screening)
• 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.

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.(Aspirin, antibiotics)
• Subject who already participated in other trials in 2months
• Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
• Heavy smokers.(>10 cigarettes per day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coadministration of G+R	gemigliptin 50mg, rosuvastatin 20mg	Coadministration of gemigliptin 50mg and rosuvastatin 20mg
Combination G/R	gemigliptin 50mg, rosuvastatin 20mg	Combination of gemigliptin 50mg / rosuvastatin 20mg

Primary Outcome Measures

Name	Time	Method
AUClast, Cmax	up to 72h post-dose	To evaluate AUClast/Cmax of gemigliptin and rosuvastatin

Secondary Outcome Measures

Name	Time	Method
Tmax	up to 72h post-dose	To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
t1/2	up to 72h post-dose	To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
CL/F	up to 72h post-dose	To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
AUCinf	up to 72h post-dose	To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin
metabolic ratio	up to 72h post-dose	To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite
AUEC	up to 72h post-dose	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.
Emax	up to 72h post-dose	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of