A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

This study has been completed.

Sponsor:

Information provided by:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT00991705

First received: October 7, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 7, 2009

Last Updated Date

October 7, 2009

Start Date ^ICMJE

July 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

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 Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Official Title ^ICMJE

An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Brief Summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: Atorvastatin
Drug: Fimasartan

Study Arm (s)

Group B
Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
Interventions:
- Drug: Atorvastatin
- Drug: Fimasartan
Group A
Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)
Interventions:
- Drug: Atorvastatin
- Drug: Fimasartan

Publications *

Shin KH, Kim TE, Kim SE, Lee MG, Song IS, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers. J Cardiovasc Pharmacol. 2011 Nov;58(5):492-9.

* 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

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

known allergy to Fimasartan and atorvastatin
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 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00991705

Other Study ID Numbers ^ICMJE

A657-BR-CT-109

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

Study Chair:

Kyung-Sang Yu, MD

Seoul National University Hospital

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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