drugset / Trial / NCT00759915
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
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, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.
Timeline
- Start
- 2006-08
- Primary completion
- 2006-09
- Completion
- 2006-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Morphine | Other / unclassified | 10 mg | Oral |
| Subject | Morphine | Other / unclassified | 20 mg | Oral |
Indications
No indication recorded.