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

BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289886

Enrollment

Registered

2011-02-04

Start date

2003-09-30

Completion date

2003-12-31

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

single-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 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.

Interventions

DRUGBR-A-657

20, 60, 120, 240, 360, 480mg or placebo tablet

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Outcome results

None listed

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