Buy morphine 60 mg
Buy morphine 60 mg,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.Buy morphine 60 mg
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.
Buy morphine 60 mg
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.