Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
Condition: Healthy
Intervention: Lansoprazole; Prevacid®
Intervention description: 30 mg Delayed-Release Capsules; 30 mg Delayed-Release Capsule
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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 fasting conditions with dosing by
      applesauce-sprinkle method.
    

Eligibility 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 who have taken any investigational drug within 30 days prior to the first
             dosing of the study 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.