NCT02767310

Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)

A Pivotal, Open-label, Balanced, Randomised, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Single Oral Dose Bioequivalence Study of Rosuvastatin/ Verisfield 20 mg Film-coated Tablets Versus Crestor/ AstraZeneca 20 mg Film-coated Tablets in Healthy Adults Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Verisfield UK Ltd. Greek Branch · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.

Detailed description

This study aims to compare the absorption and disposition kinetics of two products containing rosuvastatin under fasting conditions. These products are: Rosuvastatin/ Verisfield 20 mg film-coated tablets, a Test product manufactured by HELP S.A., Greece and Crestor™/ AstraZeneca 20 mg film-coated tablets, a Reference product manufactured by AstraZeneca, UK. The bioequivalence of a single 20 mg dose of both products will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for rosuvastatin.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rosuvastatin 20 mg film-coated tablets	Single oral dose of 20 mg
DRUG	Crestor 20 mg film-coated tablets	Single oral dose of 20 mg

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-05-10
• Last updated: 2016-07-06

Locations

1 site across 1 country: India