Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 12:46 PM
Study NCT ID:
NCT00939692
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Topiramate (2 x 25 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Topamax®, Ortho-McNeil Neurologics, Inc.)in Fasted, Healthy, Adult Subjects
Status:
COMPLETED
Status Verified Date:
2013-07
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:
* Objective:
* Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.
* Clinical Design:
* Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
* Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.
* Clinical Design:
* Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: