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Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions

NCT01164787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2010-07-19

No results posted yet for this study

Summary

The purpose of this study is

* To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed conditions to assess bioequivalence.
* To monitor adverse events and ensure safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Trandolapril

Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited

DRUG

Mavik

Mavik® 4 mg Tablets of Abbott Laboratories, USA.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Umesh Dhakate, M.B.B.S · Wellquest Clinical Research

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
2006-03-31
Primary Completion
2006-04-30
Completion
2006-05-31

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 NCT01164787 on ClinicalTrials.gov