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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 10, 2009
Last Updated Date	October 7, 2009
Start Date ^ICMJE	June 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00938197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Official Title ^ICMJE	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
Brief Summary	To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Essential Hypertension
Intervention ^ICMJE	Drug: Fimasartan Fimasartan (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d) Drug: Amlodipine Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)
Study Arm (s)	Active Comparator: Part A Intervention: Drug: Fimasartan Active Comparator: Part B Intervention: Drug: Amlodipine
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	34
Completion Date	August 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00938197
Other Study ID Numbers ^ICMJE	A657-BR-CT-107
Has Data Monitoring Committee	Yes
Responsible Party	Choi, Director, Boryung Pharmaceutical Co., Ltd
Study Sponsor ^ICMJE	Boryung Pharmaceutical Co., Ltd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Boryung Pharmaceutical Co., Ltd
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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