Dose Linearity Study of Codeine Sulfate Under Fasted Conditions

A Single Dose, 3-Period, 3-Treatment, 6-Sequence, 3-Way Crossover Study of the Dose Linearity of Codeine Sulfate Tablets Under Fasting Conditions

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

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.