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Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
This study has been completed.
First Received: September 24, 2008   Last Updated: July 21, 2009   History of Changes
Sponsored by: Actavis Inc.
Information provided by: Actavis Inc.
ClinicalTrials.gov Identifier: NCT00759954
  Purpose

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 as a sprinkle on applesauce after a 10-hour overnight fast.


Condition Intervention Phase
Healthy
Drug: morphine sulfate sustained-release capsules
Drug: KADIAN (morphine sulfate sustained-release) capsules
Phase I

Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Crossover Assignment, Bio-availability 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 Administered Orally as a Sprinkle on Applesauce

Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Maximum Plasma Morphine Concentration [ Time Frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of Maximum Plasma Morphine Concentration [ Time Frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve to the Last Measurable Time Point for Plasma Morphine [ Time Frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve to Infinity for Plasma Morphine [ Time Frame: 0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Treatment A (test product) followed by Treatment B (reference product)
Drug: morphine sulfate sustained-release capsules
1 x 200 mg, single-dose capsule
Drug: KADIAN (morphine sulfate sustained-release) capsules
2 x 100 mg, single-dose capsule
2
Treatment B (reference product) followed by Treatment A (test product)
Drug: morphine sulfate sustained-release capsules
1 x 200 mg, single-dose capsule
Drug: KADIAN (morphine sulfate sustained-release) capsules
2 x 100 mg, single-dose capsule

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breast-feeding female.
  • Subject must be between 18 and 50 years of age inclusive.
  • Subject's body weight should be within +/- 15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table and weigh a minimum of 50 kg (110 lbs).
  • Female subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
  • Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for any outpatient visits.

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to the study drug or related drugs.
  • Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to first dose of study medication.
  • Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
  • Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
  • Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • Has a history of substance abuse (including alcohol) in the past 5 years.
  • Is a female with a positive pregnancy test result.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759954

Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Daniel V. Freeland, DO CEDRA Clinical Research, LLC
  More Information

No publications provided

Responsible Party: CEDRA Clinical Research, LLC ( Daniel V. Freeland, DO )
Study ID Numbers: 20-701-1N
Study First Received: September 24, 2008
Results First Received: December 1, 2008
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00759954     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Actavis Inc.:
bioequivalence
morphine sulfate sustained release capsules
KADIAN capsules
200 mg
applesauce

Study placed in the following topic categories:
Morphine
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Healthy
Analgesics, Opioid

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009