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

BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289899

Enrollment

Registered

2011-02-04

Start date

2004-01-31

Completion date

2004-02-29

Last updated

2011-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

BR-A-657, Fimasartan, multiple-dose, pharmacokinetic, pharmacodynamic, safety

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.

Interventions

DRUGBR-A-657

120, 360mg or placebo 7days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026