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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 (Fimasartan)

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Fimasartan

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Fimasartan, healthy elderly and young male volunteer, pharmacokinetic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Part A

Part B

Arm Description

Young male healthy volunteer

Elderly male healthy volunteer

Outcomes

Primary Outcome Measures

Cmax, AUClast, tmax, t1/2

Secondary Outcome Measures

Full Information

NCT ID

NCT00937534

First Posted

July 6, 2009

Last Updated

November 2, 2009

Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Kyungpook National University Hospital, Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00937534

Brief Title

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

Acronym

Fimasartan

Official Title

An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Kyungpook National University Hospital, Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

Fimasartan, healthy elderly and young male volunteer, pharmacokinetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A

Arm Type

Active Comparator

Arm Description

Young male healthy volunteer

Arm Title

Part B

Arm Type

Active Comparator

Arm Description

Elderly male healthy volunteer

Intervention Type

Drug

Intervention Name(s)

Fimasartan

Intervention Description

Fimasartan 240mg/day

Primary Outcome Measure Information:

Title

Cmax, AUClast, tmax, t1/2

Time Frame

0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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