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Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994942
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roxane Laboratories
  Purpose
Determine the pharmacokinetics and optimize study design for subsequent studies with morphine sulfate tablets and solution.

Condition Intervention
Pain Drug: morphine sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Pharmacokinetic and Comparative Bioavailability Study of Morphine Sulfate Injection, Solution, and Tablet Formulations Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 7 days ]

Enrollment: 18
Study Start Date: April 2006
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: morphine sulfate
    morphine sulfate 30 mg tablet, morphine sulfate 30 mg (10 mg / 5 mL) oral solution, morphine sulfate injection 10 mg (1 mg / mL)
    Other Name: DURAMORPH
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994942


Locations
United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Fredrick A Bieberdorf, M.D. CEDRA Clinical Research
  More Information

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00994942     History of Changes
Other Study ID Numbers: MORP-T30-PLFS-1
First Submitted: October 9, 2009
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
Last Verified: October 2009

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