Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
- male of 18-55 years old
- BMI 19-29kg/m2
- subjects in good health
- subjects with written informed consent
- 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