NCT04895059

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20mg and Ezetimibe10mg, Fixed Dose vs Individual Components

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.)

Detailed description

To statistically compare the bioavailability of rosuvastatin 20 mg and ezetimibe 10 mg in a pharmacokinetic non-interference study, after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered separately in healthy volunteers fasting. In the same way, the safety of the presentations will be evaluated based on the registry of adverse events at the end of the three study periods. The classic 90% confidence intervals will be determined for the intra-individual ratios (test / reference) of the main parameters AUC0-t, AUC0-inf, Cmax for rosuvastatin and ezetimibe.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose	Form: Tablets Dosage: 20 mg Adminstration way: Oral
DRUG	Rosuvastatin 20mg	Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral
DRUG	Ezetimibe 10mg	Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral

Timeline

• Start date: 2017-04-30
• Primary completion: 2018-01-15
• Completion: 2018-01-22
• First posted: 2021-05-20
• Last updated: 2021-08-24

Locations

1 site across 1 country: Mexico