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

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00938197
First received: July 10, 2009
Last updated: October 7, 2009
Last verified: October 2009

July 10, 2009
October 7, 2009
June 2009
August 2009   (final data collection date for primary outcome measure)
AUCss, Cmax,ss, Tmax,ss, CLss/F [ Time Frame: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00938197 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Essential Hypertension
  • Drug: Fimasartan
    Fimasartan (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d)
  • Drug: Amlodipine
    Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)
  • Active Comparator: Part A
    Intervention: Drug: Fimasartan
  • Active Comparator: Part B
    Intervention: Drug: Amlodipine
Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00938197
A657-BR-CT-107
Yes
Choi, Director, Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP