Status:
COMPLETED
Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Pain
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Determine the pharmacokinetics and optimize study design for subsequent studies with morphine sulfate tablets and solution.
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to morphine sulfate or any comparable or similar product.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00994942
Start Date
April 1 2006
End Date
April 1 2006
Last Update
January 23 2018
Active Locations (1)
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1
CEDRA Clinical Research
Austin, Texas, United States, 78759