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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938197
• Other study ID #: A657-BR-CT-107
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2009
• Last updated: October 7, 2009
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: October 2009
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Fimasartan
Fimasartan (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d)
• Amlodipine
Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCss, Cmax,ss, Tmax,ss, CLss/F		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	Yes