Food Effect Study of Codeine Sulfate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01009892
First received: November 6, 2009
Last updated: January 17, 2014
Last verified: January 2014

November 6, 2009
January 17, 2014
January 2008
January 2008   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01009892 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Food Effect Study of Codeine Sulfate
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions

The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Codeine Sulfate
Tablet
  • Active Comparator: Codeine Sulfate, 30 mg
    tablet
    Intervention: Drug: Codeine Sulfate
  • Active Comparator: Codeine Sulfate, 60 mg
    tablet
    Intervention: Drug: Codeine Sulfate
  • Active Comparator: Codeine Sulfate, 15 mg
    tablet
    Intervention: Drug: Codeine Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01009892
CODE-T60-PVFS/FD-1
No
Roxane Laboratories
Roxane Laboratories
Not Provided
Principal Investigator: Fredrick Bieberdorf CEDRA Clinical Research
Roxane Laboratories
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP