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Bioequivalence Study of Rosuvastatin Tablet

NCT05637060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-22

No results posted yet for this study

Summary

This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects.

Conditions

  • Healthy Individuals

Interventions

DRUG

Test Drug

One single dose of Vaptor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.

DRUG

Reference Drug

One single dose of Crestor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.

Sponsors & Collaborators

  • The Searle Company Limited

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Muhammad Raza Shah, PhD · CBSCR, ICCBS, University of Karachi, Pakistan

  • Naghma Hashmi (Co-PI), PhD · CBSCR, ICCBS, University of Karachi, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2022-12-06
Completion
2022-12-15

Countries

  • Pakistan

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 NCT05637060 on ClinicalTrials.gov