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Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

Bioequivalence Clinical Trial

Official title:
A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the Two Different Products Containing 10 mg Film Coated Tablet After Oral Administration to 38 Healthy Adult Volunteers Under Fasting Conditions

Clinical Trial Summary

The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.

Clinical Trial Description

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05197517
Study type Interventional
Source Future University in Egypt
Contact
Status Completed
Phase Phase 1
Start date September 21, 2020
Completion date October 1, 2020
View Details
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