drugset / Trial / NCT00751478
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
RandomizedCrossoverDouble-blindBasic science
Summary
The purpose of the study is to determine the relative pharmacodynamic effects and safety of crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole ALO-01; to determine the relative bioavailability of plasma morphine from crushed and whole ALO-01 compared to MSIR, and from crushed ALO-01 to whole ALO-01; and to determine the relative bioavailability of plasma naltrexone and 6-β-naltrexol from crushed ALO-01 to whole ALO-01.
Timeline
- Start
- 2007-03
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALO-01 | Unknown | 120 mg | Oral |
| Comparator | Morphine | Other / unclassified | 120 mg | Oral |
Indications
No indication recorded.