A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Boryung

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fimasartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007409

A657-BR-CT-111

Details and patient eligibility

About

To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age: 20 - 45 years
• sex: male
• body weight: greater than 55 kg
• written informed consent

Exclusion criteria

• known allergy to Fimasartan
• 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
• abnormal diet which could affect drug absorption or metabolism
• positive drug or alcohol screening
• smokers of 10 or more cigarettes per day
• participation in a clinical trial during the last 60 days prior to the start of the study

Trial design

24 participants in 2 patient groups

Group B

Active Comparator group

Description:

Period 1: fed control → Period 2: fasted control

Treatment:

Drug: Fimasartan

Drug: Fimasartan

Group A

Active Comparator group

Description:

Period 1: fasted control → Period 2: fed control

Treatment:

Drug: Fimasartan

Drug: Fimasartan