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Comparative Bioavailability Study of Codeine Sulfate

Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01010152
Collaborator
(none)
34
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Codeine Sulfate
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Codeine Sulfate

30 mg tablet

Drug: Codeine Sulfate
30 mg Tablet
Other Names:
  • Tylenol #3 Tablets

    		•
    Active Comparator: Tylenol #3

    30 mg tablet

    Drug: Codeine Sulfate
    30 mg Tablet
    Other Names:
  • Tylenol #3 Tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. bioequivalence determined by statistical comparison Cmax [15 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CEDRA Clinical Research LLC San Antonio Texas United States 78217

    Sponsors and Collaborators

    • Roxane Laboratories

    Investigators

    • Principal Investigator: Fredrick Bieberdorf, M.D., CEDRA Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roxane Laboratories
    ClinicalTrials.gov Identifier:
    NCT01010152
    Other Study ID Numbers:
    • CODE-T30-PVFS-1
    First Posted:
    Nov 9, 2009
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Codeine

    Study Results

    No Results Posted as of Jan 23, 2018