Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

Completed · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01010139

Run by

Roxane Laboratories

People needed

18

Starts

2006-08-01

Expected to finish

2006-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• CEDRA Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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