BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone

NCT01662674 | Completed Phase 1

• 1 other identifier: LG-DMCL002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component 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 (1)

• AUEC

  up to 48h post-dose

Study Arms (2)

G+M

EXPERIMENTAL

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Drug: gemigliptin and metformin HCl extended release

C

EXPERIMENTAL

Combination of gemigliptin50mg/metformin HCl extended release 1000mg

Drug: gemigliptin/metformin HCl extended release

Interventions

gemigliptin and metformin HCl extended release DRUG

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day

G+M

gemigliptin/metformin HCl extended release DRUG

Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.

C

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 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)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015.

  PMID: 25678778 DERIVED

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: August 6, 2012
• First Posted: August 10, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

KR (1)