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Lansoprazole 30 mg DR Capsule Replicate Food Study

NCT01046084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-12-08

Study results available
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Summary

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Lansoprazole

30 mg Delayed-Release Capsule

DRUG

Prevacid®

30 mg Delayed-Release Capsule

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Walter Parham, M.D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2003-09-30
Completion
2003-09-30

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 NCT01046084 on ClinicalTrials.gov