central diabetes insipidus and nocturnal enuresis central diabetes insipidus and nocturnal enuresis
Conditions
Interventions
Dosing on desmopressin tablet and MINIRINMELT OD Tablet
DESM-ODT-1001, MINIRINMELT
Sponsors
Kondo Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese adult healthy volunteer
Exclusion criteria
Exclusion criteria: Individuals who are institutionalized Individuals whose dietary or exercise habits have recently changed significantly Individuals whom the investigator determines to have any condition, such as an infectious disease, that may interfere with safe participation in the clinical trial Individuals who cannot undergo venipuncture Individuals who have received an investigational drug in another clinical trial within 30 days prior to the first administration of the investigational drug in this trial Individuals with food allergies, food intolerances (non-allergic food hypersensitivity), dietary restrictions, or those who require a special diet Individuals with allergies or hypersensitivity to desmopressin, related products, or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the bioequivalence of Viatris desmopressin acetate orally disintegrating tablet, 240 mcg administered with or without water to Ferring MINIRINMELT OD Tablets, 240 mcg administered with or without water following administration of a single, oral 240 mcg,1 x 240 mcg, dose administered under fasting conditions in healthy adult Japanese volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary objectives, monitoring of the safety and tolerability of desmopressin given as orally disintegrating tablet will be performed. | — |
Contacts
Public ContactYuko Kondo
Viatris Pharmaceuticals Japan G.K.
Outcome results
None listed