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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289886
• Other study ID #: 2290/2
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2010
• Last updated: February 3, 2011
• Start date: September 2003
• Est. completion date: December 2003

Study information

• Verified date: January 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 single oral dose of BR-A-657 in healthy male subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

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

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: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose; Vital signs: Pre dose*, 0.5, 1*, 2, 4*, 6, 8*, 12 and 24* h post dose (*:both supine and standing); ECG: Pre dose, 2, 4, 8 and 24 h post dose; Clinical laboratory examination: Pre dose and 24 h post dose; Physical examination: predose, 5~7days post dose; Body weight: predose, 5~7days post dose	up to 5~7days post-dose	Yes
Secondary	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	Yes
Secondary	Maximum observed plasma concentration (Cmax)		0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes