Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01131702
Status:
COMPLETED
Last Update Posted:
2010-06-09
First Post:
2010-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: