Clinical trial NCT01046253: Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
Official title: A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

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.

Primary outcomes:
measure: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 12 hour period.
measure: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
timeFrame: Blood samples collected over a 12 hour period.
measure: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
timeFrame: Blood samples collected over a 12 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: St. Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Ali Ziaee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: