NCT00782548

Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults

A Phase IV, Comparative, Randomized, Double Blind, Single-Dose, 2-way Crossover Study to Evaluate the Pharmacokinetics and Safety of Alpharma Branded Products Division (KADIAN)and Ligand Pharmaceuticals Inc. (Avinza) 30 mg Morphine Sulfate Sustained-Release Capsules in Healthy Adult Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30 mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed conditions. The secondary objective of this study was to evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KADIAN (morphine sulfate sustained-release) capsules	Capsules, 30 mg
DRUG	Avinza (morphine sulfate sustained-release) capsules	Capsules, 30 mg

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2008-10-31
• Last updated: 2020-07-16

Locations

1 site across 1 country: United States