Comparative Bioavailability Study of Codeine Sulfate

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2008

Interventions

  • Drug: Codeine Sulfate
    • 30 mg Tablet

Arms, Groups and Cohorts

  • Experimental: Codeine Sulfate
    • 30 mg tablet
  • Active Comparator: Tylenol #3
    • 30 mg tablet

Clinical Trial Outcome Measures

Primary Measures

  • bioequivalence determined by statistical comparison Cmax
    • Time Frame: 15 days

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Roxane Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fredrick Bieberdorf, M.D., Principal Investigator, CEDRA Clinical Research

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