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Bioequivalence study of Prazosin 5mg tablet of Amin Pharm Co., IRA

Not Applicable
Conditions
Hypertension.
Essential (primary) hypertension
Registration Number
IRCT20190706044111N27
Lead Sponsor
Amin Pharm. Co.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
24
Inclusion Criteria

Aged between 18 - 50 years
Body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination
Understand the procedures and give written informed consent

Exclusion Criteria

History of the gastro-intestinal tract surgery
Subject with a history of blood donation or participation in another clinical trial, within the last two months before the first treatment
Subject with a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject with a history of disease leading to using drug within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma concentration of prazosin after single dose of 5mg prazosin tablet. Timepoint: at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 & 10.0 hr. after dosing. Method of measurement: High Performance Liquid Chromatography (HPLC).
Secondary Outcome Measures
NameTimeMethod
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