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

Phase 1

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: BR-A-657

• Registration Number: NCT01289899
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2010-12-14
• Status Verified: 2011-02
• Study First Submitted QC: 2011-02-03
• Last Update Submitted: 2011-02-03
• Study First Posted: 2011-02-04
• Last Update Posted: 2011-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BR-A-657	BR-A-657 120mg or placebo
Arm B	BR-A-657	BR-A-657 360mg or placebo

Primary Outcome Measures

Name	Time	Method
No of subjects with Adverse events(AE) from each observations	up to 5~7days post final(7th) dose	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

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration time curve (AUC)	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Maximum observed plasma concentration (Cmax).	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
parent plasma terminal elimination half life (t½)	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Apparent total plasma clearance (CL/F)	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Accumulation ratio (RA)	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7	RA1=Accumulation ratio based on AUCinf; RA2=Accumulation ratio based on Cmax