Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide
      from 2 tablet products and determine if the 2 products were bioequivalent to each other.
    

Detailed description: 
      This was a single center, single-dose, randomized, open-label, two-treatment, two-period
      crossover bioequivalence study designed to evaluate the pharmacokinetics and bioequivalence
      of morphine sulfate formulations under fed conditions. Normal healthy males and females at
      least 18 years of age were screened for enrollment into the trial.

      Potential subjects who met the eligibility criteria randomly received either oral Morphine
      Sulfate 60 mg Extended-release tablets or oral MS Contin® 60 mg Controlled-release tablets on
      Day 1 in Period 1, then, following the washout period, they were dosed on Day 8 in Period 2
      with the other treatment. There was a 7-day washout period between dosing. The study drug
      treatments were administered following the Food and Drug Administration (FDA) high-fat
      breakfast, which was served after subjects had been fasting for 11 hours. Fasting resumed
      until 4 hours post-dose for both treatment groups. All enrolled subjects were administered
      single oral doses of 50 mg of naltrexone hydrochloride 10 hours predose, 1 hour predose, and
      12 hours post-dose of the study drug treatment on Day -1 and Day 1 in Period 1 and on Day 7
      and Day 8 in Period 2. Potential subjects (ie, alternates) were administered single oral
      doses of 50 mg of naltrexone hydrochloride 10 hours predose and 1 hour predose of the study
      drug treatment on Day -1 and Day 1 in Period 1.

      Subjects visited the clinic at Screening (within 28 days prior to dosing) to assess
      eligibility and returned to the clinic on Day -1 for the Period 1 confinement period that
      lasted through Day 2. To complete Period 1, subjects were to return on Day 3 for the
      collection of pharmacokinetic blood samples. Period 1 dosing was followed by the 7-day
      washout period. Subjects returned to the clinic for the Period 2 confinement period on Day 7,
      which continued through Day 9. To complete Period 2, subjects were to return on Day 10 in
      that period for the collection of pharmacokinetic and safety blood samples.

      Pharmacokinetic and safety assessments were performed during the conduct of the trial. Blood
      samples for the evaluation of morphine and morphine-6-glucuronide plasma concentrations were
      obtained while subjects were at the clinic and after discharge, as appropriate.
      Pharmacokinetic samples were collected over a 48-hour period of time following administration
      of the study drug treatment.

      Medical care of the subjects was assured by the presence of a physician for at least 4 hours
      post-dose, and the physician remained on-call to treat adverse events (AEs). Professional
      medical personnel were on-site during the entire study confinement period. Adverse event
      information elicited during confinement at the clinic or during telephone contacts was
      reviewed and documented.
    

Intervention name(s): Morphine Sulfate
Intervention type(s): Drug
Intervention description(s): Morphine Sulfate 60mg Extended-release tablets
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)