Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00778232
Status:
COMPLETED
Last Update Posted:
2008-10-23
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2008-10
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:
This study compared the relative bioavailability (rate and extent of absorption) of Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers under non-fasting conditions.
Detailed Description:
A single oral dose of the test or the reference product was administered to 22 healthy adult human volunteers on two separate occasions under non-fasting conditions with at least a 7 day washout between the doses. Food and the fluid intake were controlled during each confinement period.
Twenty two (22) healthy adult human volunteers (12 males and 10 females) were enrolled in the study. All twenty two (22) subjects successfully completed the clinical portion of the study
Twenty two (22) healthy adult human volunteers (12 males and 10 females) were enrolled in the study. All twenty two (22) subjects successfully completed the clinical portion of the study
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?: