BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

Phase 1

• Conditions: Healthy
• Interventions: Drug: gemigliptin/metformin HCl extended release; Drug: gemigliptin and metformin HCl extended release

• Registration Number: NCT02670018
• Lead Sponsor: LG Life Sciences

Brief Summary

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-12
• Study First Submitted: 2015-12-22
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-29
• Last Update Submitted: 2016-01-31
• Study First Posted: 2016-02-01
• Last Update Posted: 2016-02-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Age between 19 to 45, healthy male subjects(at screening)
• Body weight between 55kg - 90kg, 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 3months
• Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
• Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	gemigliptin/metformin HCl extended release	Combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets
G+M	gemigliptin and metformin HCl extended release	Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets

Primary Outcome Measures

Name	Time	Method
AUClast	up to 48h post-dose	To evaluate AUClast of gemigliptin and metformin
Cmax	up to 48h post-dose	To evaluate Cmax of gemigliptin and metformin

Secondary Outcome Measures

Name	Time	Method
AUCinf of Gemigliptin, Metformin	up to 48h post-dose
t1/2 of Gemigliptin, Metformin	up to 48h post-dose
CL/F of Gemigliptin, Metformin	up to 48h post-dose
Vd/F of Gemigliptin, Metformin	up to 48h post-dose
AUC0-48h of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
Cmax of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
Tmax of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
AUCinf of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
Tmax of Gemigliptin, Metformin	up to 48h post-dose
t1/2 of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
CL/F of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
Vd/F of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose
metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)	up to 48h post-dose

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of