Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT00864760
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-08
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 relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis under fasting conditions.
Detailed Description:
Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover design under fasting conditions
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets versus 400 mg Gabapentin Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets versus 400 mg Gabapentin Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study Oversight
Has Oversight DMC:
False
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?: