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

NCT04895059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-08-24

No results posted yet for this study

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.)

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Araceli G Medina Nolasco, M.D · Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2018-01-15
Completion
2018-01-22

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895059 on ClinicalTrials.gov