Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions
Condition: Healthy
Intervention: morphine sulfate sustained-release capsules; KADIAN (morphine sulfate sustained-release) capsules
Intervention description: 1 x 200 mg, single-dose capsule; 2 x 100 mg, single-dose capsule
Intervention MeSH terms: Morphine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence; morphine sulfate sustained release capsules; KADIAN capsules; 200 mg

Summary:

      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
      after a 10-hour overnight fast.
    

Eligibility 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.