Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

NCT01010139 — Not applicable, Completed, 18 participants, Roxane Laboratories

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A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions

Registry	NCT01010139
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	18 (Actual)
Sponsor	Roxane Laboratories (Industry)
Conditions	Pain
Interventions	Codeine Sulfate (Drug)
Dates	start 2006-08-01, primary completion 2006-09-01, completion 2006-09-01, first posted 2009-11-09, last updated 2018-01-23
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Codeine Sulfate (Drug): 15 mg, 30 mg and 60 mg Tablet

+Outcome measures

Primary outcomes

bioequivalence determined by statistical comparison Cmax [21 Days]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
CEDRA Clinical Research	San Antonio, Texas	United States

+Investigators

James P Doherty, DO, Principal investigator, CEDRA Clinical Research

My Notes

Public

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