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

NCT01007409 | Completed Phase 1

• 1 other identifier: A657-BR-CT-111
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cmax, Tmax, AUC, T1/2, CL/F etc.

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours

Study Arms (2)

Group B

ACTIVE COMPARATOR

Period 1: fed control → Period 2: fasted control

Drug: Fimasartan

Group A

ACTIVE COMPARATOR

Period 1: fasted control → Period 2: fed control

Drug: Fimasartan

Interventions

Fimasartan DRUG

Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast

Group B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

MeSH Terms

Interventions

fimasartan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 4, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-12