Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects

Boryung Pharmaceutical Co., Ltd16 enrolled

Overview

The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.

BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects. Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects. PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Essential Hypertension

Interventions

BR-A-657DRUG

120, 360mg or placebo 7days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * male of 18-55 years old * BMI 19-29kg/m2 * subjects in good health * subjects with written informed consent Exclusion Criteria: * subjects with multiple drug allergy or allergy to ARB * subjects with medication that affect drug absorption or elimination within 30days. * subjects with orthostatic hypotension of \>20mmHg decrease of sbp * subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder

Outcomes

Primary Outcomes

No of subjects with Adverse events(AE) from each observations

1. AE reporting: Day 1: Predose, 3 \& 12h, Days 2\~7: Predose, Days 8,9: Once daily, 5\~7days post final dose 2. Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3\~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5\~7days post final dose 3. ECG: Days 1 \& 7: Predose, 2, 4, 8 \& 24h, Day 4: Predose, 5\~7days post final dose 4. Laboratory examination: Days 1 \& 4: Predose, Day 7: Predose \& 24h, 5\~7days post final dose 5. Physical examination: predose, 5\~7days post final dose 6. Body weight: predose, Days 4 \& 8

Time frame: up to 5~7days post final(7th) dose