NCT01131702

Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions

Randomized,2-way Crossover, Bioequivalence Study of Ranitidine 300 mg Tablets Zantac 300 mg Tablets Administered as 1 x 300 mg Tablet in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.

Detailed description

This study compared the rate and extent of absorption of ranitidine 300 rng tablets versus Zantac. The study products were administered as a single oral dose of 1 x 300 mg tablet using a randomized, two-way crossover fasting study in non-smoker healthy volunteers with a washout period of 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ranitidine	Ranitidine Tablets, 300 mg

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-02-01
• Completion: 2003-03-01
• First posted: 2010-05-27
• Last updated: 2010-06-09

Locations

1 site across 1 country: Canada