Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-04-15 @ 8:53 AM
Study NCT ID:
NCT00864305
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 400 mg Capsules Under Non-fasting Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-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:
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food
Detailed Description:
Study Type: Interventional Study Design: Single dose, randomized, three-period, three-treatment, six-sequence crossover study under non-fasting conditions (test and reference) and fasting (test) conditions
Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules
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?: