Calendario›SUPN›SPN-812

SPN-812

Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women

Ensayo de SUPERNUS PHARMACEUTICALS, INC. en Healthy Lactating Women (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

15

previstos

Centros

1

Fin del objetivo primario

sep 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2023.

Qué mide

AUCtau,Milk (Day 3: -4 to <0 hours pre-dose, and '0 to 4', '4 to 6', '6 to 8', '8 to 10', '10 to 12', '12 to 16' and '16 to 24' hours post-dose.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk following repeated administration of SPN-812 600 mg, QD. This study is comprised of Screening, Inpatient Admission, Treatment Period and End of Study (EOS). The total duration of the study is up to 32 days including Screening up to 28 days and 4 days of Treatment Period. Subjects will remain in the inpatient unit for 5 days, including the day of admission to the inpatient unit (Day -1), 3 days of dosing SM (Days 1-3), and the day of discharge (Day 4).

Más ensayos de SUPN

Todos los de SUPN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06259331), actualizada en jun 2024.