NCT01270308

Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions

Open Label, Randomized, Two-treatment, Three-period, Three-sequence, Partial Replicate Oral Bioequivalence Study of Lansoprazole 30 mg DR Capsules of Dr.Reddy's Laboratories Limited, India Comparing With That of PREVACID® (Containing Lansoprazole) 30 mg DR Capsules of TAP Pharmaceuticals Inc. USA, in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.

Detailed description

open label, randomized, two-treatment, three-period, three-sequence, partial replicate oral bioequivalence study of Lansoprazole 30 mg DR Capsules of Dr.Reddy's Laboratories Limited, India comparing with that of PREVACID® (containing Lansoprazole) 30 mg DR Capsules of TAP Pharmaceuticals Inc. USA, in healthy, adult, human subjects under fasting conditions. 48 healthy, adult, human subjects were enrolled in the study and 42 subjects were completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lansoprazole	Lansoprazole DR Capsules 30 mg

Timeline

• Start date: 2008-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2011-01-05
• Last updated: 2011-01-05

Locations

1 site across 1 country: India