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

Phase 1

Completed

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

• Registration Number: NCT01289886
• 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 single oral dose of BR-A-657 in healthy male subjects.

Detailed Description

BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to 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: 2003-09
• Primary Completion: 2003-11
• Study Completion: 2003-12
• Study First Submitted: 2010-12-13
• Status Verified: 2011-01
• 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: 40

Inclusion Criteria

• male of 18-55 years old
• Body Mass Index(BMI) 19-29kg/m2
• subjects in good health
• subjects with written informed consent

Exclusion Criteria

• subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)
• subjects with medication that affect drug absorption or elimination within 30days.
• subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP)
• subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, 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 20mg or placebo
Arm B	BR-A-657	BR-A-657 60mg or placebo
Arm C	BR-A-657	BR-A-657 120mg or placebo
Arm E	BR-A-657	BR-A-657 480mg or placebo
Arm D	BR-A-657	BR-A-657 240mg or placebo

Primary Outcome Measures

Name	Time	Method
No of subjects with Adverse events(AE) from each observations	up to 5~7days post-dose	1. AE reporting: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose; 2. Vital signs: Pre dose\*, 0.5, 1\*, 2, 4\*, 6, 8\*, 12 and 24\* h post dose (\*:both supine and standing); 3. ECG: Pre dose, 2, 4, 8 and 24 h post dose; 4. Clinical laboratory examination: Pre dose and 24 h post dose; 5. Physical examination: predose, 5\~7days post dose; 6. Body weight: predose, 5\~7days post dose

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration time curve (AUC)	0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Maximum observed plasma concentration (Cmax)	0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Time of the maximum observed plasma concentration (Tmax)	0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent total plasma clearance (CL/F)	0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent plasma terminal elimination half life (t½)	0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h