Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-07 @ 2:40 AM
Study NCT ID:
NCT00759902
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Randomized Two-way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Formulation of KADIAN (2 x 10mg) Capsules Compared to a KADIAN 20 mg Capsule in Healthy Adult Subjects Under Fasted Conditions
Status:
COMPLETED
Status Verified Date:
2010-08
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 single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma Branded Products Inc. following an overnight fast of at least 10 hours.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: