Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
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The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
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.