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

Essential Hypertension Clinical Trial

— Fimasartan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937534
• Other study ID #: A657-BR-CT-104
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2009
• Last updated: November 2, 2009
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: November 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Fimasartan
Fimasartan 240mg/day

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Kyungpook National University, Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, AUClast, tmax, t1/2		0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h	Yes