Bioequivalence study of Aristatin 40mg tablet of Arya Pharm Co., IRA

Not Applicable

Recruiting

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

• Registration Number: IRCT20190706044111N14
• Lead Sponsor: Arya Pharm Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• 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 and more 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 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.
Subject had a history of allergic to statins
Concurrency of the first treatment with menstruation period
Seasonal allergy
Dyspepsia

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. after drug administration. Method of measurement: High Performance Liquid Chromatography (HPLC).