Phase 1Completed
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
- Sponsor
- Verisfield UK Ltd. Greek Branch (Industry)
- Enrolment
- 49 enrolled
- Conditions
- Healthy
- Interventions
- Rosuvastatin 20 mg film-coated tablets; Crestor 20 mg film-coated tablets
- Ages
- adults
- Registry
- NCT02767310
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area under the plasma concentration (AUC0-t) from zero (0) hours to time (t)
- Maximum concentration (Cmax)
History
Last registry update
Primary completion
Started
Registered