Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

NCT01426399 | Completed Phase 1

• 1 other identifier: LG-DPCL009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss

  To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

  up to 171h30m

• Cmax,ss

  To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

  up to 171h 30m

Secondary Outcomes (3)

• Vital signs

  up to 171h30m

• AUECτ,ss

  up to 171h30m

• AUEC

  up to 171h30m

Study Arms (3)

LC15-0444

EXPERIMENTAL

LC15-0444 50mg qd

Drug: LC15-0444

Metformin

EXPERIMENTAL

Metformin 1000mg bid

Drug: Metformin

LC15-0444+Metformin

EXPERIMENTAL

LC15-0444 50mg qd +Metformin 1000mg bid

Drug: LC15-0444+Metformin

Interventions

LC15-0444 DRUG

LC15-0444 50mg qd (8 days once daily)

LC15-0444

Metformin DRUG

Metformin 1000 mg bid (8 days twice daily)

Metformin

LC15-0444+Metformin DRUG

LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

LC15-0444+Metformin

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 2months
• 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)

• Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3.

  PMID: 24627290 DERIVED

MeSH Terms

Interventions

LC15-0444; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kyung-sang Yu, M.D,Ph.D

  Seoul national univ. hospital

  PRINCIPAL INVESTIGATOR

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 22, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

KR (1)