Comparative Bioavailability Study of Codeine Sulfate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01010152
First received: November 6, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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
Pain
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

  Eligibility

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

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

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov 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:
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014