Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

This study has been completed.
Sponsor:
Collaborators:
Kyungpook National University
Seoul National University Hospital
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00937534
First received: July 6, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.


Condition Intervention Phase
Essential Hypertension
Drug: Fimasartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Cmax, AUClast, tmax, t1/2 [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A
Young male healthy volunteer
Drug: Fimasartan
Fimasartan 240mg/day
Active Comparator: Part B
Elderly male healthy volunteer
Drug: Fimasartan
Fimasartan 240mg/day

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, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers.

22 male healthy volunteers were enrolled during 2 months.

In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age

    • young: 19-45 years
    • elderly: more than 65 years
  • sex: male
  • body weight: greater than 55 kg

Exclusion Criteria:

  • patients with contraindication to angiotensin II receptor antagonist.
  • patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
  • patients with history or diseases which might affect absorption of the drug
  • patients with HIV, type B or C hepatitis
  • smokers of 20 or more cigarettes per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Choi, Director, Boryung Pharm Co., Inc
ClinicalTrials.gov Identifier: NCT00937534     History of Changes
Other Study ID Numbers: A657-BR-CT-104
Study First Received: July 6, 2009
Last Updated: November 2, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
healthy elderly and young male volunteer
pharmacokinetic

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014