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

Condition Intervention Phase
Pain Drug: Codeine Sulfate Phase 1

Study Type: Interventional
Study Design: 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 Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]

Enrollment: 36
Study Start Date: January 2008
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Codeine Sulfate, 30 mg
tablet
Drug: Codeine Sulfate
Tablet
Active Comparator: Codeine Sulfate, 60 mg
tablet
Drug: Codeine Sulfate
Tablet
Active Comparator: Codeine Sulfate, 15 mg
tablet
Drug: Codeine Sulfate
Tablet

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01009892


Locations
United States, Texas
CEDRA Clinical Research
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Fredrick Bieberdorf CEDRA Clinical Research
  More Information

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01009892     History of Changes
Other Study ID Numbers: CODE-T60-PVFS/FD-1
First Submitted: November 6, 2009
First Posted: November 9, 2009
Last Update Posted: January 20, 2014
Last Verified: January 2014

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