NCT00759759

Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered after a 10-hour overnight fast.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	morphine sulfate sustained-release capsules	1 x 200 mg, single-dose capsule
DRUG	KADIAN (morphine sulfate sustained-release) capsules	2 x 100 mg, single-dose capsule

Timeline

• Start date: 2004-09-01
• Primary completion: 2004-09-01
• Completion: 2004-10-01
• First posted: 2008-09-25
• Last updated: 2010-08-17
• Results posted: 2009-09-01

Locations

1 site across 1 country: United States