Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Morphine

Criteria

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 morphine sulfate or any comparable or similar product.