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Bioequivalence Study of Rosuvastatin Tablet — BE  

Healthy Individuals Clinical Trial

Official title:
A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Vaptor 20mg (Rosuvastatin) Tablet and Crestor 20mg (Rosuvastatin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects

Clinical Trial Summary

This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects.

Clinical Trial Description

This is a single-center, open-label, randomized, single-dose, two-period, two-way, cross-over study. Subjects will receive one single dose per treatment period of Test and Reference Drugs separated by a wash-out period of 7 days. Blood samples will be taken up to 72 hours post-dose. The primary pharmacokinetic parameters will be compared for both drugs to assess the bioequivalence. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05637060
Study type Interventional
Source University of Karachi
Contact
Status Completed
Phase N/A
Start date November 24, 2022
Completion date December 15, 2022
View Details
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