Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT02549469
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2015-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
Status:
COMPLETED
Status Verified Date:
2015-09
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:
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
Detailed Description:
None
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?: