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GLPG1972
A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines
Ensayo de Lakefront Biotherapeutics NV en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 18
- Centros
- 1
- Fin del objetivo primario
- dic 2019
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2019.
Qué mide
Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations (From Day 1 pre-dose up to Day 4) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.
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Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04137341), actualizada en ene 2020.