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drugset / Trial / NCT01045967

Lansoprazole 30 mg DR Capsule Fasting Study

NCT01045967 ↗

Phase 1 Completed 56 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

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.

Timeline

Start
2004-05
Primary completion
2004-06
Completion
2004-07

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 105 (90% CI 90.7 to 122) NCT01045967 ↗

registry Ratio of the T/R geometric mean x 100 97.2 (90% CI 86.1 to 110) NCT01045967 ↗

registry Ratio of the T/R geometric mean x 100 97.4 (90% CI 86.3 to 110) NCT01045967 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lansoprazole Other / unclassified 30 mg —

Indications

No indication recorded.