NCT00759902

Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	morphine sulfate extended-release capsules	2 x 10 mg, single-dose capsule
DRUG	KADIAN (morphine sulfate extended-release) capsules	1 x 20 mg, single-dose capsule

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-10-01
• First posted: 2008-09-25
• Last updated: 2010-08-17
• Results posted: 2009-09-01

Locations

1 site across 1 country: United States