We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Food Effect Study of Codeine Sulfate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01009892
First Posted: November 9, 2009
Last Update Posted: January 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxane Laboratories
November 6, 2009
November 9, 2009
January 20, 2014
January 2008
January 2008   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]
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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01009892
CODE-T60-PVFS/FD-1
No
Not Provided
Not Provided
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
To Top