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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:
West-Ward Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Codeine Sulfate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions
Study Start Date : August 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Codeine Sulfate
    15 mg, 30 mg and 60 mg Tablet


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 Days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010139


Locations
United States, Texas
CEDRA Clinical Research
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: James P Doherty, DO CEDRA Clinical Research

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01010139     History of Changes
Other Study ID Numbers: CODE-T60-PLFS-1
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents