Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions|
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]Bioequivalence based on Cmax.
- AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]Bioequivalence based on AUC0-t.
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]Bioequivalence based on AUC0-inf.
|Study Start Date:||January 2004|
|Study Completion Date:||January 2004|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
Experimental: Investigational Test Product
Lansoprazole 30 mg Delayed-Release Capsule
30 mg Delayed-Release Capsules
Active Comparator: Reference Listed Drug
Prevacid® 30 mg Delayed-Release Capsule
30 mg Delayed-Release Capsule
Other Name: Lansoprazole (generic name)
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
|United States, Missouri|
|Gateway Medical Research, Inc.|
|St. Charles, Missouri, United States, 63301|
|Principal Investigator:||Ali Ziaee, M.D.||Cetero Research, San Antonio|