Status:

COMPLETED

Dose Proportionality and Food Effect of Morphine Sulfate

Lead Sponsor:

Roxane Laboratories

Conditions:

Pain

Eligibility:

All Genders

18-45 years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2007

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00994539

Start Date

January 1 2007

End Date

February 1 2007

Last Update

January 23 2018

Active Locations (1)

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CEDRA Clinical Research

Austin, Texas, United States, 78759