Food Effect Study of Codeine Sulfate

Completed · Phase 1

Conditions studied: Pain

In brief

The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet

Key facts

Study ID

NCT01009892

Run by

Roxane Laboratories

People needed

36

Starts

2008-01-01

Expected to finish

2008-01-01

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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