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Lansoprazole 30 mg DR Capsule Fasting Study

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01045967
First received: January 8, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

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 fasting conditions.


Condition Intervention Phase
Healthy
 Drug: Lansoprazole
Drug: Prevacid®
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Cmax.

  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-t.

  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-inf.


Enrollment: 56
Study Start Date: May 2004
Study Completion Date: July 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Invesigational Test Product
Lansoprazole 30 mg delayed-release Capsules
 Drug: Lansoprazole
30 mg delayed-release Capsule
Active Comparator: Reference Listed Drug
Prevacid® 30 mg delayed-release Capsules
 Drug: Prevacid®
30 mg delayed-release Capsule
Other Name: Lansoprazole (generic name)

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smokers or light smokers (10 or less cigarettes per day)
  • 18 years of age or older
  • Body Mass Index of 30 or less
  • Males or non-pregnant females
  • Normal clinical laboratory test results

Exclusion Criteria:

  • Subjects with a significant history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing.
  • Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.
  • Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045967

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01045967     History of Changes
Other Study ID Numbers: B046530
Study First Received: January 8, 2010
Results First Received: February 22, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013