drugset / Trial / NCT00759759

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

NCT00759759

Phase 1 Completed 36 enrolled Actavis Inc.
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2004-09
Primary completion
2004-09
Completion
2004-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 200 mg Oral

Indications

No indication recorded.