A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 150 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).
The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of the 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Tempe, Arizona, Estados Unidos
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m2, inclusive
- Must have a body weight of not less than 50 kg - Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
Exclusion Criteria:
- History of or current clinically significant medical illness
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
- History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- Known allergy to heparin or history of heparin induced thrombocytopenia
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
Plan de estudios
¿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 A
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 4 tablets of metformin extended release (MET XR), 500 mg each, administered together under fed conditions.
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Cada comprimido contiene canagliflozina (CANA) de 300 mg para tomar por vía oral (por la boca).
Otros nombres:
Cada tableta contiene metformina de liberación prolongada (MET XR), 500 mg, para tomar por vía oral (por la boca).
Otros nombres:
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Experimental: Tratamiento B
Cada participante recibirá una dosis única de 2 tabletas de CANA/MET XR FDC, formulación 1, en condiciones de alimentación.
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Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.
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Experimental: Tratamiento C
Cada participante recibirá una dosis única de 2 tabletas de CANA/MET XR FDC, formulación 2, en condiciones de alimentación.
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Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Plasma concentration of canagliflozin following administration of a single dose of study drug
Periodo de tiempo: Predose, (before tablet intake) up to 72 hours after dose
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Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
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Predose, (before tablet intake) up to 72 hours after dose
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Plasma concentration of metformin following administration of a single dose of study drug
Periodo de tiempo: Predose, up to 36 hours after dose
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Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
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Predose, up to 36 hours after dose
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Percentage of participants with adverse events as a measure of safety and tolerability
Periodo de tiempo: Screening, up to Day 10 of the follow-up period
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Screening, up to Day 10 of the follow-up period
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR103256
- 28431754DIA1044 (Otro identificador: Janssen Research & Development, LLC)
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