A Single Dose, 3-Period, 3-Treatment, 6-Sequence, 3-Way Crossover Study of the Dose Linearity of Codeine Sulfate Tablets Under Fasting Conditions
| Registry | NCT01009697 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 34 (Actual) |
| Sponsor | Roxane Laboratories (Industry) |
| Conditions | Pain |
| Interventions | Codeine Sulfate (Drug) |
| Dates | start 2008-03-01, primary completion 2008-04-01, completion 2008-04-01, first posted 2009-11-09, last updated 2018-01-23 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Pain All trials of Codeine Sulfate
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
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| CEDRA Clinical Research | Austin, Texas | United States |