Clinical Trials Logo
  1. Home
  2. Essential Hypertension
  3. NCT00923533

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

Essential Hypertension Clinical Trial

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

Clinical Trial Summary

To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00923533
Study type Interventional
Source Boryung Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date March 2009
Completion date August 2009
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03708601 - Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
Not yet recruiting NCT05503953 - Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS Phase 3
Recruiting NCT05526703 - Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy Phase 3
Completed NCT06395194 - Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension Phase 3
Not yet recruiting NCT06418074 - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity N/A
Completed NCT02890173 - Study of CS-3150 in Patients With Essential Hypertension Phase 3
Withdrawn NCT02096939 - Microvascular Function in Primary Aldosteronism N/A
Completed NCT02944734 - Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension Phase 2
Recruiting NCT01956786 - Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine Phase 2/Phase 3
Completed NCT02553512 - Helius in Hypertension-I: The UK Hypertension Registry N/A
Completed NCT01198249 - Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension Phase 1
Completed NCT01001572 - Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension Phase 3
Recruiting NCT00380289 - Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension N/A
Completed NCT00139698 - Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension Phase 3
Completed NCT00288184 - Uric Acid in Essential Hypertension in Children Phase 2
Completed NCT01289886 - Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects Phase 1
Not yet recruiting NCT06041529 - Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension Phase 4
Completed NCT04470830 - A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
Completed NCT00758524 - A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension Phase 2
Recruiting NCT05109013 - Juvenile Essential Arterial Hypertension and Vascular Function