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Dose Proportionality and Food Effect of Morphine Sulfate

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00994539
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Drug: morphine sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Study of the Dose Proportionality of and Effect of Food on Morphine Sulfate Tablets.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2007
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: morphine sulfate
    morphine sulfate 15 mg and 30 mg tablets
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994539

Locations
United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00994539     History of Changes
Other Study ID Numbers: MORP-T30-PVFS-2
Study First Received: October 9, 2009
Last Updated: October 13, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013