Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborator: Covance

Criteria

Inclusion Criteria:

• male of 18-55 years old

• Body Mass Index(BMI) 19-29kg/m2

• subjects in good health

• subjects with written informed consent

Exclusion Criteria:

• subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)

• subjects with medication that affect drug absorption or elimination within 30days.

• subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP)

• subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder