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A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

Information source: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Fimasartan (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boryung Pharmaceutical Co., Ltd

Summary

To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Clinical Details

Official title: An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

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

Primary outcome: AUC, Cmax, Tmax, CL/F

Detailed description: Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20 mg ~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose. A open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide. 34 male healthy volunteers were enrolled during 2 months. In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0. 5, 1, 1. 5, 2, 2. 5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day. In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0. 5, 1, 1. 5, 2, 2. 5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- age: 20 - 45 years

- sex: male

- body weight: greater than 55 kg

- written informed consent

Exclusion Criteria:

- known allergy to Fimasartan and hydrochlorothiazide

- 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

Locations and Contacts

Additional Information

Starting date: March 2009
Last updated: October 7, 2009

Page last updated: August 23, 2015

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