Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg
NCT01929512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2013-08-30
Summary
To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state, respectively.
Conditions
Interventions
- DRUG
-
HCP1201 750/20mg
750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
- DRUG
-
Metformin SR 750mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
- DRUG
-
Rosuvastatin 20mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Sponsors & Collaborators
-
Hanmi Pharmaceutical Company Limited
lead INDUSTRY
Principal Investigators
-
JaeWook Ko, MD, PhD · Samsung Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- South Korea
Study Locations
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