Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | January 2007 |
| End Date: | January 2007 |
A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Comparative Bioavailability Study of Morphine Sulfate Immediate Release Tablets and Solution and Controlled Release Capsules Under Steady-State Conditions.
Characterize the steady-state pharmacokinetics of morphine after oral administration of
Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to
compare their pharmacokinetics to that of AVINZA.
Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to
compare their pharmacokinetics to that of AVINZA.
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to morphine sulfate or any comparable or
similar product.
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