Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 45
Updated:1/25/2018
Start Date:April 2006
End Date:April 2006

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A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Pharmacokinetic and Comparative Bioavailability Study of Morphine Sulfate Injection, Solution, and Tablet Formulations Under Fasting Conditions.

Determine the pharmacokinetics and optimize study design for subsequent studies with morphine
sulfate tablets and solution.


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 morphine sulfate or any comparable or
similar product.
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