NCT05637060

Bioequivalence Study of Rosuvastatin Tablet

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Karachi · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Individuals

Interventions

Type	Name	Description
DRUG	Test Drug	One single dose of Vaptor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.
DRUG	Reference Drug	One single dose of Crestor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.

Timeline

• Start date: 2022-11-24
• Primary completion: 2022-12-06
• Completion: 2022-12-15
• First posted: 2022-12-05
• Last updated: 2023-03-22

Locations

1 site across 1 country: Pakistan