Comparative Bioavailability Study of Codeine Sulfate

Completed · Phase 1

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT01010152

Run by

Roxane Laboratories

People needed

34

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 LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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