Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
NCT01426399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2011-12-30
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
Interventions
- DRUG
-
LC15-0444
LC15-0444 50mg qd (8 days once daily)
- DRUG
-
Metformin 1000 mg bid (8 days twice daily)
- DRUG
-
LC15-0444+Metformin
LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)
Sponsors & Collaborators
-
LG Life Sciences
lead INDUSTRY
Principal Investigators
-
Kyung-sang Yu, M.D,Ph.D · Seoul national univ. hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2011-11-30
- Completion
- 2011-12-31
Countries
- South Korea
Study Locations
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