Status:

COMPLETED

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

Lead Sponsor:

Boryung Pharmaceutical Co., Ltd

Conditions:

Essential Hypertension

Eligibility:

MALE

20-40 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • age: 20 - 40 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2009

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00938197

Start Date

June 1 2009

End Date

August 1 2009

Last Update

October 8 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul National University Hospital

Seoul, South Korea