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
Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 29 Apr 2017
At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease; Cardiac oedema; Hyponatraemia; Oedema; Renal failure
- Focus Pharmacokinetics
- Sponsors Otsuka Pharmaceutical
- 25 Apr 2017 Status changed from recruiting to active, no longer recruiting.
- 24 Apr 2017 Planned End Date changed from 1 Dec 2017 to 1 Aug 2017.
- 24 Apr 2017 Planned primary completion date changed from 1 Mar 2017 to 1 Aug 2017.