At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed
In Brief
A Phase 1 clinical trial evaluating Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg, and 1 other intervention for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
Monocentric study of no pharmacokinetic interaction between rosuvastatin 20 mg and ezetimibe 10 mg. An open design, randomized, single dose with three periods, six sequences and crossed, in healthy volunteers with fasting conditions, managed in fixed dose combination (Sponsor Laboratorios Silanes S.A. de C.V.) versus individual components managed by separated (Crestor®, product of Astrazeneca, S.A. de C.V and Ezetrol®. product of Undra S.A. de C.V.)
Study Details
Timeline
Interventions
Form: Tablets Dosage: 20 mg Adminstration way: Oral
Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral
Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral