Overview
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Status:
Completed
Completed
Trial end date:
2009-08-01
2009-08-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteersPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boryung Pharmaceutical Co., LtdTreatments:
Amlodipine
Criteria
Inclusion Criteria:- age: 20 - 40 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Exclusion Criteria:
- known allergy to Fimasartan and amlodipine
- existing cardiac or hematological diseases
- existing hepatic and renal diseases
- existing gastrointestinal diseases
- acute or chronic diseases which could affect drug absorption or metabolism
- history of any serious psychological disorder
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day 3 month ago
- participation in a clinical trial during the last 2 months prior to the start of the
study