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
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
- 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.