Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

Completed · Not applicable

Conditions studied: Pain

In brief

Characterize the steady-state pharmacokinetics of morphine after oral administration of Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of AVINZA.

Key facts

Study ID

NCT00994383

Run by

Roxane Laboratories

People needed

36

Starts

2007-01-01

Expected to finish

2007-01-01

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 morphine sulfate or any comparable or similar product.

Where it is running

• CEDRA Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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