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

NCT02670018 | Unknown Phase 1

• 1 other identifier: LG-DMCL005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

Study Arms (2)

G+M

ACTIVE COMPARATOR

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets

Drug: gemigliptin and metformin HCl extended release

C

EXPERIMENTAL

Combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets

Drug: gemigliptin/metformin HCl extended release

Interventions

gemigliptin and metformin HCl extended release DRUG

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets, for 1 day

G+M

gemigliptin/metformin HCl extended release DRUG

Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets, for 1day

C

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

LC15-0444

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: February 1, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)