Journal of Bioequivalence & Bioavailability

Thomas Barrett

Publications

• Research Article
  Steady-State Pharmacokinetics of MNK-795, an Extended-Release Oxycodone and Acetaminophen Combination Analgesic: Results from 2 Active Comparator Studies
  Author(s): Krishna Devarakonda, Terri Morton, Michael Giuliani, Kenneth Kostenbader and Thomas BarrettKrishna Devarakonda, Terri Morton, Michael Giuliani, Kenneth Kostenbader and Thomas Barrett
  
  Two single-center, open-label, randomized, phase 1, multiple-dose studies (N=48 each) evaluated the steadystate pharmacokinetics and tolerability of MNK-795, a bilayer product with both immediate-release (IR) and extendedrelease (ER) components of oxycodone (OC) and acetaminophen (APAP; OC/APAP ER). Study 1 compared 1- and 2-tablet doses of OC/APAP ER (7.5 mg/325 mg; 15 mg/650 mg) administered every 12 hours and 1 tablet of IR OC/ APAP (7.5 mg/325 mg) administered every 6 hours over 4.5 days. Study 2 compared OC/APAP ER administered as 2 tablets (15 mg/650 mg) every 12 hours with IR oxycodone (15 mg), IR tramadol/APAP (37.5 mg/325 mg), and IR OC/APAP (7.5 mg/325 mg), each administered as 1 tablet every 6 hours over 4.5 days. In both studies, steady-state, dose-normalized, AUC0-12h, Cavg, and Cmin for oxycodone were similar between OC/APAP ER and each comparator; however, the degree of.. View More»
  DOI: 10.4172/jbb.1000180

  Abstract PDF