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Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions

NCT01645449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2012-07-20

No results posted yet for this study

Summary

The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Atorvastatin Calcium Tablets, 80 mg

Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. med. Margarete Muller · Nuvisan Pharma Services GmbH & Co. KG

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
2010-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Germany

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 NCT01645449 on ClinicalTrials.gov