Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 11:08 PM
Study NCT ID:
NCT01009892
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2009-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect Study of Codeine Sulfate
Sponsor:
Roxane Laboratories
Organization:
Study Overview
Official Title:
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions
Status:
COMPLETED
Status Verified Date:
2018-01
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 study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate 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?: