Dose Proportionality and Food Effect of Morphine Sulfate

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT00994539
• Lead Sponsor: Roxane Laboratories

Brief Summary

Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	15 days

Trial Locations

Locations (1)

CEDRA Clinical Research; 🇺🇸 Austin, Texas, United States