Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release
This study has been completed.
Information provided by:
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
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.
Drug: morphine sulfate
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Comparative Bioavailability Study of Morphine Sulfate Immediate Release Tablets and Solution and Controlled Release Capsules Under Steady-State Conditions.
Primary Outcome Measures:
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2007 (Final data collection date for primary outcome measure)
Drug: morphine sulfate
morphine sulfate 30 mg tablet, morphine sulfate 15 mg tablet, morphine sulfate controlled release 120 mg
Other Name: AVINZA
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994383
|CEDRA Clinical Research
|Austin, Texas, United States, 78759 |
||Fredrick A Bieberdorf, M.D.
||CEDRA Clinical Research
No publications provided
||Elizabeth Ernst, Director, Drug Regulatory Affair and Medical Affairs, Roxane Laboratories, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2009
||October 13, 2009
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants