Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Condition: Healthy
MeSH terms: Disease
Intervention: morphine sulfate extended-release capsules; KADIAN (morphine sulfate extended-release) capsules
Intervention description: 2 x 10 mg, single-dose capsule; 1 x 20 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: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence; 10 mg; KADIAN capsules; 20 mg; under fasted conditions

Summary:

      The objective of this single-dose, open-label, randomized, two-treatment, two-period
      crossover study was to compare the relative bioavailability of a test formulation of KADIAN
      (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the
      commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma
      Branded Products Inc. following an overnight fast of at least 10 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be a male or non-pregnant, non-breast-feeding female.

          -  Subject must be between 18 and 55 years of age (inclusive).

          -  Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and
             subject must 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, at least from screening through completion of the study. Approved
             forms of contraception are abstinence, hormonal (oral, implant, transdermal or
             injection) in use at least 3 consecutive months prior to first dose of study
             medication, double barrier (condom and diaphragm with spermicide), intra-uterine
             device (IUD), or vasectomized partner (6 months minimum since vasectomy).

          -  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 all 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,
             ECG or clinical laboratory results at screening.

          -  History or presence of allergic or adverse response to the KADIAN 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 nutritional supplements,
             within 7 days prior to the first dose of study medication.

          -  Has used any prescription medication, except hormonal contraceptive or hormonal
             replacement therapy, within 14 days prior to the first dose of study medication.

          -  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 treatment for 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.