Bioequivalence study of Rosuvastatin 20mg of Sobhan Darou Pharm Co.

Not Applicable

• Conditions: Hyperlipidemia.; Hyperlipidemia, unspecified; E78.5

• Registration Number: IRCT20190706044111N15
• Lead Sponsor: Sobhan Darou Pharm. Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 March 2020

Recruitment & Eligibility

• Status: Complete
• 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 showed clinically relevant deviations from normal in physical examination (BMI less than 18 or mor than 25, ... )
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 three 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.
Subject had a history of allergic to statins

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Rosuvastatin. Timepoint: At 0 (before dosing), 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 24.0 & 48.0 hr. post-dose. Method of measurement: High Performance Liquid Chromatography (HPLC).