Ignite Creation Date:
2024-05-05 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00650052
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2008-03-30
Brief Title:
Fasting Study of Zonisamide Capsules 100 mg and Zonegran Capsules 100 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Viatris Inc
Study Overview
Official Title:
Single-Dose Fasting In Vivo Bioequivalence Study of Zonisamide Capsules 100 mg Mylan to Zonegran Capsules 100 mg Elan in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-04
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 objective of this study was to investigate the bioequivalence of Mylans zonisamide 100 mg capsules to Elans Zonegran 100 mg capsules following a single oral 100 mg 1 x 100 mg dose administered under fasting conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None