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

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: gemigliptin and metformin HCl extended release; Drug: gemigliptin/metformin HCl extended release

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G+M; Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets	Drug: gemigliptin and metformin HCl extended release; Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets, for 1 day
Experimental: C; Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets	Drug: gemigliptin/metformin HCl extended release; Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	To evaluate AUClast of gemigliptin and metformin	up to 48h post-dose
Cmax	To evaluate Cmax of gemigliptin and metformin	up to 48h post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax of Gemigliptin, Metformin	up to 48h post-dose
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
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

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): February 2, 2016
• Last Update Submitted That Met QC Criteria: January 31, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: LG-DMCL005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO