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Sponsored by: |
Actavis Inc. |
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Information provided by: | Actavis Inc. |
ClinicalTrials.gov Identifier: | NCT00759356 |
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: morphine sulfate sustained-release capsules Drug: KADIAN |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Under Fed Conditions |
Enrollment: | 36 |
Study Start Date: | August 2004 |
Study Completion Date: | September 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Treatment A (test product) followed by Treatment B (reference product)
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Drug: morphine sulfate sustained-release capsules
1 x 200 mg, single-dose capsule
Drug: KADIAN
2 x 100 mg, single-dose capsule
|
2
Treatment B (reference product) followed by Treatment A (test product)
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Drug: morphine sulfate sustained-release capsules
1 x 200 mg, single-dose capsule
Drug: KADIAN
2 x 100 mg, single-dose capsule
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
CEDRA Clinical Research, LLC | |
Austin, Texas, United States, 78759 |
Principal Investigator: | Daniel V. Freeland, DO | CEDRA Clinical Research, LLC |
Responsible Party: | CEDRA Clinical Research, LLC ( Daniel V. Freeland, DO ) |
Study ID Numbers: | 20-700-1N |
Study First Received: | September 24, 2008 |
Results First Received: | December 5, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00759356 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bioavailability KADIAN 200 mg |
morphine sulfate sustained release capsules 100 mg fed conditions |
Morphine Malnutrition Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Healthy Analgesics, Opioid |
Morphine Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |