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PrimeC 748 mg

A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

Ensayo de NeuroSense Therapeutics Ltd. en Farmacocinetica.

Fase

Fase 1

Estado

Completado

Participantes

19

previstos

Centros

1

Fin del objetivo primario

ago 2022

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Cmax D1 (del registro, en inglés) (1 dia)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions. The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.

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Ficha completa en ClinicalTrials.gov (NCT05436678), actualizada en feb 2023.