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Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01010139
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:

November 6, 2009
November 9, 2009
January 23, 2018
August 2006
September 2006   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 Days ]
Same as current
Complete list of historical versions of study NCT01010139 on ClinicalTrials.gov Archive Site
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Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions
The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
Drug: Codeine Sulfate
15 mg, 30 mg and 60 mg Tablet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2006
September 2006   (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
 
 
NCT01010139
CODE-T60-PLFS-1
No
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Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: James P Doherty, DO CEDRA Clinical Research
West-Ward Pharmaceutical
January 2018

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