A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue Relative to Oral Administration of One 60 mg Dexlansoprazole Delayed-Release Capsule in Healthy Subjects
Dexlansoprazole Delayed Release Orally Disintegrating Tablets
+ Dexlansoprazole Delayed Release Capsules
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2014
Fecha en la que se inscribió al primer participante.The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole. The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods: * Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days * One dexlansoprazole 60 mg capsule for 5 days. All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study. This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment. The overall time to participate in this study is up to 57 days.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 52 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 55 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios