Comparative Bioavailability 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 objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

Condition Intervention Phase
Drug: Codeine Sulfate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting 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: 15 days ] [ Designated as safety issue: No ]

Enrollment: 34
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
Experimental: Codeine Sulfate
30 mg tablet
Drug: Codeine Sulfate
30 mg Tablet
Other Name: Tylenol #3 Tablets
Active Comparator: Tylenol #3
30 mg tablet
Drug: Codeine Sulfate
30 mg Tablet
Other Name: Tylenol #3 Tablets


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT01010152

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

No publications provided

Responsible Party: Roxane Laboratories Identifier: NCT01010152     History of Changes
Other Study ID Numbers: CODE-T30-PVFS-1
Study First Received: November 6, 2009
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses processed this record on November 24, 2015