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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 03, 2015
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents