Official Title: “A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions”

The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Codeine Sulfate
  • 30 mg Tablet

Primary Measures

• bioequivalence determined by statistical comparison Cmax
  • Time Frame: 15 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Roxane Laboratories

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010152

Study ID Number: CODE-T30-PVFS-1

ClinicalTrials.gov Identifier: NCT01010152

Health Authority: United States: Institutional Review Board