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PrimeC-ER 748 mg

A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects

Ensayo de NeuroSense Therapeutics Ltd. en Farmacocinetica.

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

1

Fin del objetivo primario

abr 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2022.

Qué mide

AUC 0-t (del registro, en inglés) (1 mes)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable). In one period of the study, PrimeC-ER tablets will be administered to subjects following an overnight fast of at least 10 hours. In a second period of the study, PrimeC-ER tablets will be administered to subjects at 30 minutes following the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In a third period of the study, a single 750 mg dose of ciprofloxacin and a single 200 mg dose of celecoxib will be co-administered to subjects following an overnight fast of at least 10 hours. The order of administration will follow a six-sequence randomization schedule. Blood samples will be collected at pre-dose and at intervals over 48 hours after dosing in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before dosing until 48 hours after dosing in each study period. The interval between doses will be at least 7 days. Subjects will return to the clinical facility 7 days (± 1 day) after the last study drug administration for an end-of study follow-up visit.

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Todos los de NRSN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05232461), actualizada en oct 2022.