A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

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

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

1. Male 19-50 years of age.

2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.

3. Medically healthy with no clinically significant medical history.

4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.

2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

3. Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.

4. Plasma donation within a month prior to the first dose of study drug.

5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).