Comparison of Pediatric Formulation (liquid) to Adult Formulation (tablets)

Update Il y a 4 ans
Reference: EUCTR2014-004350-34

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

To evaluate the comparative bioavailability between: • MK-5348 (vorapaxar) 0.2085 mg/mL oral suspension from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA; and • MK-5348 (Zontivity™) 2.08 mg tablet (equivalent to 2.5 mg vorapaxar sulfate) from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA; after a single-dose in healthy subjects under fasting conditions.


Inclusion criteria

  • Vorapaxar is indicated for the reduction of thrombotic cardiovascular
  • events in patients with a history of myocardial infarction (MI) or with
  • peripheral
  • arterial disease (PAD)

Links