Drug-drug Interaction Study (CKD-501, Ketoconazole)
NCT01330563 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2011-06-29
Summary
The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.
Conditions
Interventions
- DRUG
-
CKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Sponsors & Collaborators
-
Severance Hospital
collaborator OTHER -
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Minsoo Park · Severance 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
- 2011-03-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- South Korea
Study Locations
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