Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fasting 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 fasted 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 after almost a 12-hour fast. Fasting continued until slightly
      over 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 AAIPharma 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)