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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289899
• Other study ID #: 2290/9
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2010
• Last updated: February 3, 2011
• Start date: January 2004
• Est. completion date: February 2004

Study information

• Verified date: February 2011
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• BR-A-657
120, 360mg or placebo 7days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Covance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No of subjects with Adverse events(AE) from each observations	AE reporting: Day 1: Predose, 3 & 12h, Days 2~7: Predose, Days 8,9: Once daily, 5~7days post final dose; 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; ECG: Days 1 & 7: Predose, 2, 4, 8 & 24h, Day 4: Predose, 5~7days post final dose; Laboratory examination: Days 1 & 4: Predose, Day 7: Predose & 24h, 5~7days post final dose; Physical examination: predose, 5~7days post final dose; Body weight: predose, Days 4 & 8	up to 5~7days post final(7th) dose	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Accumulation ratio (RA)	RA1=Accumulation ratio based on AUCinf; RA2=Accumulation ratio based on Cmax	predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7	Yes