Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00759954
First received: September 24, 2008
Last updated: August 13, 2010
Last verified: August 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


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 ]
    calculated from drug concentration over time


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 ]
    calculated from drug concentration over time

  • 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 ]
    calculated from drug concentration over time

  • 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
Other Names:
  • Treatment A
  • Test product
Drug: KADIAN (morphine sulfate sustained-release) capsules
2 x 100 mg, single-dose capsule
Other Names:
  • Treatment B
  • Reference product
2
Treatment B (reference product) followed by Treatment A (test product)
Drug: morphine sulfate sustained-release capsules
1 x 200 mg, single-dose capsule
Other Names:
  • Treatment A
  • Test product
Drug: KADIAN (morphine sulfate sustained-release) capsules
2 x 100 mg, single-dose capsule
Other Names:
  • Treatment B
  • Reference product

  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
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: 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: Daniel V. Freeland, DO, CEDRA Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT00759954     History of Changes
Other Study ID Numbers: 20-701-1N
Study First Received: September 24, 2008
Results First Received: December 1, 2008
Last Updated: August 13, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014