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A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions

ClinicalTrials.gov · COMPLETED, 2004

56 participants

Abstract

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.

Conditions: Healthy.

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma); AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration); AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity).

Enrollment: 56 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 56 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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