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Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition

NCT01167894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-07-22

No results posted yet for this study

Summary

The purpose of this study is to

* compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fasting conditions
* monitor adverse events and to ensure the safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Simvastatin

Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mangesh Kulkarni · Vimta Labs Limited, Hyderabad, India, 500 051

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-04-30
Completion
2005-04-30

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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 NCT01167894 on ClinicalTrials.gov