Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01010139

First Posted: November 9, 2009

Last Update Posted: November 9, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Roxane Laboratories

Purpose

The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.

Condition	Intervention
Pain	Drug: Codeine Sulfate


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Codeine Sulfate ion

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 Days ]


Enrollment:	18
Study Start Date:	August 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Intervention Details:

15 mg, 30 mg and 60 mg Tablet

Eligibility

Information from the National Library of Medicine

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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

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): NCT01010139

Locations


United States, Texas
CEDRA Clinical Research
San Antonio, Texas, United States, 78217

Sponsors and Collaborators

Roxane Laboratories

Investigators


Principal Investigator:	James P Doherty, DO	CEDRA Clinical Research

More Information


Responsible Party:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT01010139 History of Changes
Other Study ID Numbers:	CODE-T60-PLFS-1
First Submitted:	November 6, 2009
First Posted:	November 9, 2009
Last Update Posted:	November 9, 2009
Last Verified:	November 2009

Additional relevant MeSH terms:


Codeine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs	Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents

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