Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

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.

Timeline

Start

2004-01

Primary completion

2004-01

Completion

2004-01

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 105 (90% CI 97.4 to 114) NCT01046253 ↗

registry Ratio of the T/R geometric mean x 100 98.5 (90% CI 93.3 to 104) NCT01046253 ↗

registry Slope 98 (90% CI 92.8 to 104) NCT01046253 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lansoprazole	Other / unclassified	30 mg	—

Indications

No indication recorded.