Dose Proportionality and Food Effect of Morphine Sulfate

A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Study of the Dose Proportionality of and Effect of Food on Morphine Sulfate Tablets.

Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.

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.