NCT01711749

Rosuvastatin Calcium Bioequivalence Study - Fast

Study of Bioequivalence Between Two Formulations of 20 mg Rosuvastatin Calcium Tablets, Administered Under Fasting to Healthy Volunteers of Both Genders, Being the Test Formulation Manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda. and the Reference Formulation (Crestor®) Commercialized by AstraZeneca do Brasil Ltda.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent.

Detailed description

The objective of this study is to confirm if two formulations of rosuvastatin calcium 20 mg tablets are bioequivalent. Test formulation is rosuvastatin calcium 20 mg tablets - manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brazil Ltda., administration of one single-dose tablet. Reference formulation is rosuvastatin calcium 20 mg tablets (Crestor® 20 mg - AstraZeneca do Brasil Ltda.), administration of one single-dose tablet. Sixty-four healthy volunteers, of both genders, with age ranging from 18 and 50 years old, will receive test or reference formulation under fasting conditions, according to the randomization list. In each period, after administration of medication, blood samples are collected at the following times: 0:00 (prior to administration), 0:30, 1:00, 1:30, 2:00, 2:20, 2:40: 3:00, 3:20, 3:40, 4:00, 4:20, 4:40, 5:00, 5:30, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 and 72:00 hours. The comparative bioavailability of formulations is evaluated based on relevant pharmacokinetic parameters for statistical comparison. Such parameters are obtained directly from the determination of the drug active principle plasmatic concentration, based on the application of a non-compartmental pattern for the evaluation of these concentrations after the drug oral administration.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Crestor®	Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor®
DRUG	rosuvastatin calcium tablets	Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda.

Timeline

• Start date: 2013-02-25
• Primary completion: 2013-03-13
• Completion: 2013-03-13
• First posted: 2012-10-22
• Last updated: 2017-06-20

Locations

1 site across 1 country: Brazil