Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants
18 de noviembre de 2014 actualizado por: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release (IR) 1 x (50 mg/500 mg) With Respect to the Metformin IR Tablet (Locally Sourced From Canada [Glucophage, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects
The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin tablet in healthy fed and fasted participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants.
The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4).
All eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions.
Blood samples will be collected at pre-dose and post-dose of study treatment, for understanding the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time).
Participants' safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Nebraska
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Lincoln, Nebraska, Estados Unidos
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m^2) (inclusive) and a body weight of not less than 50 kg
Exclusion Criteria:
- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treatment Sequence ABDC
Treatment A (canagliflozin and metformin immediate release [IR] fixed dose combination [FDC] tablet 50 milligram [mg]/500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
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Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
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Experimental: Treatment Sequence BCAD
Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
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Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
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Experimental: Treatment Sequence CDBA
Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
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Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
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Experimental: Treatment Sequence DACB
Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
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Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Concentración plasmática de canagliflozina
Periodo de tiempo: 2 horas después de la dosificación
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Las concentraciones plasmáticas de canagliflozina se usan para evaluar cuánta canagliflozina hay en la sangre, 2 horas después de la administración.
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2 horas después de la dosificación
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Plasma Concentration of Metformin
Periodo de tiempo: Pre-dose up to 24 hours post-dose
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Plasma concentrations of metformin are used to evaluate how much metformin is in the blood over time.
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Pre-dose up to 24 hours post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Eventos adversos
Periodo de tiempo: Hasta aproximadamente 58 días
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La cantidad y el tipo de eventos adversos se informarán desde el Día 1 del período de tratamiento 1 hasta los 5-7 días posteriores al período de tratamiento 4, incluido un período de lavado de 7+/- 1 día entre los períodos de tratamiento (el tiempo total es de aproximadamente 58 días).
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Hasta aproximadamente 58 días
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Signos vitales
Periodo de tiempo: Hasta aproximadamente 58 días
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Se evaluarán la presión arterial, el pulso y la temperatura corporal oral.
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Hasta aproximadamente 58 días
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Clinical Laboratory Tests
Periodo de tiempo: Up to approximately 58 days
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Clinically relevant changes occurring in laboratory safety parameters will be evaluated.
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Up to approximately 58 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2014
Finalización primaria (Actual)
1 de octubre de 2014
Finalización del estudio (Actual)
1 de octubre de 2014
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2014
Publicado por primera vez (Estimar)
19 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
18 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR104979
- 28431754DIA1070 (Otro identificador: Janssen Research & Development, LLC)
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