Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | March 2008 |
| End Date: | April 2008 |
A Single Dose, 3-Period, 3-Treatment, 6-Sequence, 3-Way Crossover Study of the Dose Linearity of Codeine Sulfate Tablets Under Fasting Conditions
The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg,
30 mg, and 60 mg codeine sulfate tablets under fasted conditions
30 mg, and 60 mg codeine sulfate tablets under fasted conditions
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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