Completado
A Phase 1, Randomized, Open-Label, Four-Period Crossover, Multiple-Dose, Single-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety Following Administration of Oral Doses of 10, 20 and 40 mg of Ilaprazole and 40 mg of Esomeprazole in Healthy Subjects
Qué se está evaluando
Ilaprazole
+ Esomeprazole
+ Ilaprazole
Medicamento
Quiénes están siendo reclutados
De 18 a 55 años
+8 Criterios de eligibilidad
Cómo está diseñado el estudio
Fase 1
Intervencional
Inicio del estudio: febrero de 2005
Resumen
Patrocinador PrincipalIl-Yang Pharm. Co., Ltd.
Última actualización: 28 de marzo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 1 de febrero de 2005
Fecha en la que se inscribió al primer participante.The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1) and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg, 20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days; and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets for 5 consecutive days.
Patrocinador PrincipalIl-Yang Pharm. Co., Ltd.
Última actualización: 28 de marzo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Detalles del Diseño
Se reclutarán 40 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Criterios
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
7 criterios de inclusión requeridos para participar
At the Screening Visit, subject had a body mass index (BMI) within the range of 18 to 30 kg/m2, as determined by the following calculation
Female subject was using, and agreed to continue the use of, a double-barrier method of birth control. Oral, patch, implants, or injectable contraceptives were accepted as 1 method if the subject had been taking them for greater than 2 months at the Screening Visit. Subjects who had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy for a minimum of 6 months, or surgical sterilization of partner (vasectomy for 6 months minimum), or were postmenopausal (defined as the absence of menses for 2 years or the absence of menses for 12 months and follicle-stimulating hormone [FSH] level of > 40 IU/L) did not require the use of birth control
Pregnancy test results for all females were negative in order to enter and remain in the study. A serum pregnancy test was performed on all females at Screening, Day -1 of each period, and Day 6 of Period 4 only, or if a subject prematurely discontinued. Results must have been negative in order for study drug to be administered
Prior to any study-specific procedures being performed, the subject voluntarily signed the approved informed consent/PIPEDA authorization form after having it fully explained and all questions answered
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Un criterio de exclusión impide participar
Subject had current evidence of cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction; serious allergy, asthma, history of significant sensitivity to any drug; or lactose intolerance that would contraindicate taking ilaprazole or esomeprazole or would interfere with the conduct of the study
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Grupos de Tratamiento
Objetivos del Estudio
4 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Grupo II
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Grupo III
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Grupo IV
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Completado1 Centros de Estudio