Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | June 2008 |
| End Date: | June 2008 |
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10
mg Tablets under fasting conditions
mg Tablets under fasting 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 oxymorphone hydrochloride
or any comparable or similar product.
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