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Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)

NCT02767310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-07-06

No results posted yet for this study

Summary

The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.

Conditions

  • Healthy

Interventions

DRUG

Rosuvastatin 20 mg film-coated tablets

Single oral dose of 20 mg

DRUG

Crestor 20 mg film-coated tablets

Single oral dose of 20 mg

Sponsors & Collaborators

  • Verisfield UK Ltd. Greek Branch

    lead INDUSTRY

Principal Investigators

  • Kathiria Jayesh, M.D. · Synchron Research Services Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • India

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 NCT02767310 on ClinicalTrials.gov