Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

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

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Kyungpook National University; Kyungpook National University Hospital; Seoul National University Hospital

Criteria

Inclusion Criteria:

• age

• young: 19-45 years

• elderly: more than 65 years

• sex: male

• body weight: greater than 55 kg

Exclusion Criteria:

• patients with contraindication to angiotensin II receptor antagonist.

• patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases

• patients with history or diseases which might affect absorption of the drug

• patients with HIV, type B or C hepatitis

• smokers of 20 or more cigarettes per day