Food Effect 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, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions
The study was designed to assess the effect of food on the absorption of codeine from Roxane
Laboratories' 60 mg Codeine Sulfate tablet
Laboratories' 60 mg Codeine Sulfate tablet
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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