Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-20 @ 12:54 PM
Study NCT ID:
NCT00653003
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
Sponsor:
Par Pharmaceutical, Inc.
Organization:
Study Overview
Official Title:
To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2017-09
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 single-dose Bioavailability of Kali and Aventis
Detailed Description:
To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy female subjects under fed conditions
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?: