Steady State Study of Codeine Sulfate
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | January 2008 |
| End Date: | January 2008 |
A Single Dose, 1-Period, 1-Treatment Study of Codeine Sulfate 15 mg Tablets Under Steady State Conditions
Study to characterize the steady-state pharmacokinetics of codeine and its metabolites
morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral
administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15
mg Q4H x 5 days.
morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral
administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15
mg Q4H x 5 days.
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 codeine sulfate or any comparable or
similar product.
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