Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01065987
Status:
COMPLETED
Last Update Posted:
2010-02-10
First Post:
2010-02-08
Brief Title:
Bioequivalence Study of Tizanidine HCl 4mg Tablets of DrReddys Under Fed Conditions
Sponsor:
Dr Reddys Laboratories Limited
Organization:
Dr Reddys Laboratories Limited
Study Overview
Official Title:
Randomized 2-way Crossover Bioequivalence Study of Tizanidine Hydrochloride 4mg Tablets and Zanaflex 4mg Tablets Administered As 1 x 4mg Tablet in Healthy Adult Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2010-02
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 bioequivalence study is to compare the test tizanidine Hydrochloride 4mg tablets of DrReddys Laboratories Limited with reference zanaflex 4mg tablets of Elan in healthy adult subjects under fed conditions
Detailed Description:
Randomized 2-way crossover bioequivalence study of tizanidine Hydrochloride 4mg tablets and zanaflex 4mg tablets administered As 1 x 4mg tablet in healthy adult subjects under fed conditions
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