Calendario›EOCN›Aramchol

Aramchol

Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers

Ensayo de Galmed Pharmaceuticals Ltd. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

64

previstos

Centros

1

Fin del objetivo primario

sep 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2016.

Qué mide

Maximum plasma concentration (Cmax) (Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004. This study will consist of two parts and the subjects will be assigned to two parts. In each part of the study, subjects will be enrolled in the study within 28 days of screening.

Más ensayos de EOCN

Todos los de EOCN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02803996), actualizada en dic 2016.