Overview
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
Status:
Completed
Completed
Trial end date:
2008-04-01
2008-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 conditionsPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Roxane LaboratoriesTreatments:
Codeine
Criteria
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.