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Food Effect Study of Codeine Sulfate

This study has been completed.
Information provided by (Responsible Party):
Roxane Laboratories Identifier:
First received: November 6, 2009
Last updated: January 17, 2014
Last verified: January 2014
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
Drug: Codeine Sulfate
Active Comparator: Codeine Sulfate, 60 mg
Drug: Codeine Sulfate
Active Comparator: Codeine Sulfate, 15 mg
Drug: Codeine Sulfate


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

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
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Please refer to this study by its identifier: NCT01009892

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

Responsible Party: Roxane Laboratories Identifier: NCT01009892     History of Changes
Other Study ID Numbers: CODE-T60-PVFS/FD-1
Study First Received: November 6, 2009
Last Updated: January 17, 2014

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on September 20, 2017