Pharmacokinetic and Comparative Bioavailability 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: | August 2006 |
| End Date: | September 2006 |
A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions
The objective of this study designed to characterize the pharmacokinetics and comparative
bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of
60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.
bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of
60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg 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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