Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01161927
Status:
COMPLETED
Last Update Posted:
2010-07-14
First Post:
2010-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Non-fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-07
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 experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
Detailed Description:
Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.
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?: