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Comparative Bioavailability Study of Codeine Sulfate

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ClinicalTrials.gov Identifier: NCT01010152
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Codeine Sulfate Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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 Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions
Study Start Date : January 2008
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ]

Eligibility Criteria
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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
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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): NCT01010152


Locations
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United States, Texas
CEDRA Clinical Research LLC
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Roxane Laboratories
Investigators
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Principal Investigator: Fredrick Bieberdorf, M.D. CEDRA Clinical Research
More Information
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Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01010152    
Other Study ID Numbers: CODE-T30-PVFS-1
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Codeine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents