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A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

NCT01380431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-06-27

No results posted yet for this study

Summary

The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).

Conditions

  • To Determine Bioequivalence Under Fed Conditions

Interventions

DRUG

Lisinopril

Tablets, 40 mg, single oral dose

DRUG

lisinopril

Tablets, 40 mg, single, oral dose

DRUG

Lisinopril

50% of subjects received the Par formulated product.

Sponsors & Collaborators

  • PharmaKinetics Laboratories Inc.

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Clifford L Ferguson, MD · PharmaKinetics Laboratories Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
1999-08-31
Primary Completion
1999-10-31
Completion
1999-10-31

Countries

  • United States

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 NCT01380431 on ClinicalTrials.gov