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Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions

NCT01164761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-07-19

No results posted yet for this study

Summary

The purpose of this study is

* To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting conditions and to assess the bioequivalence.
* To monitor the safety of the subjects.

Conditions

  • Healthy

Interventions

DRUG

Ramipril

Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited

DRUG

Altace

Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mr. Charu Gautam, MD, DNB · Lambda Therapeutic Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-09-30
Completion
2005-10-31

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 NCT01164761 on ClinicalTrials.gov