A Single-center, Open-label, Randomized, 3-Period, 3-Way, Crossover Bioequivalence Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

Trial Profile

A Single-center, Open-label, Randomized, 3-Period, 3-Way, Crossover Bioequivalence Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 19 Oct 2017

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease; Cardiac oedema; Hyponatraemia; Oedema; Renal failure
  • Focus Pharmacokinetics
  • Sponsors Otsuka Pharmaceutical
  • Most Recent Events

    • 13 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 18 Sep 2017 Planned End Date changed from 1 Aug 2017 to 1 Nov 2017.
    • 18 Sep 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Nov 2017.
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