Bioequivalence study of Dapoxetine 30mg tablet of Alborz Darou Pharm Co., IRA
Not Applicable
- Conditions
- Premature ejaculation.Premature ejaculationF52.4
- Registration Number
- IRCT20190706044111N18
- Lead Sponsor
- Alborzdarou 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
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication 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
Name Time Method Plasma concentration of dapoxetine. Timepoint: At 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after drug administration. Method of measurement: High Performance Liquid Chromatography (HPLC).
- Secondary Outcome Measures
Name Time Method