Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water

Phase 1 Completed 32 enrolled Actavis Inc.

RandomizedCrossoverOpen-labelBasic science

Summary

The objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules when dosed with alcohol under fasting and fed conditions compared to water.

Timeline

Start: 2006-05
Primary completion: 2006-07
Completion: 2006-07

Publications

Results Johnson F, Wagner G, Sun S, Stauffer J. Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008 Apr;9(4):330-6. doi: 10.1016/j.jpain.2007.11.009. Epub 2008 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alcohol	Other / unclassified	240 ml	Oral
Subject	Morphine	Other / unclassified	20 mg	Oral
Subject	Morphine	Other / unclassified	100 mg	Oral

Indications

No indication recorded.