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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01289886
Other study ID # 2290/2
Secondary ID
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


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
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