drugset / Trial / NCT00759902

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

NCT00759902

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

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.

Timeline

Start
2006-08
Primary completion
2006-09
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 10 mg Oral
Subject Morphine Other / unclassified 20 mg Oral

Indications

No indication recorded.