A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Boryung

Status and phase: Completed; Phase 1

Conditions: Essential Hypertension

Treatments: Drug: Amlodipine; Drug: Fimasartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938197

A657-BR-CT-107

Details and patient eligibility

About

To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

Enrollment: 34 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Part A

Active Comparator group

Treatment:

Drug: Fimasartan

Part B

Active Comparator group

Treatment:

Drug: Amlodipine