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

History of Changes

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:

Drug Information available for: Codeine Acetaminophen Sulfate ion Codeine phosphate

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Analgesics, Opioid Antitussive Agents Central Nervous System Agents Central Nervous System Depressants Narcotics	Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

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