- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01332071
Avandamet Bioequivalence Study Brazil - Fed Administration
14 de junio de 2017 actualizado por: GlaxoSmithKline
Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods.
The volunteers received, in each period, the reference or the test formulation after standardized meals.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals.
Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets.
Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets.
The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years.
Their body mass index (BMI) varied between 18,5 and 25.
There are no restrictions regarding the ethnic group.
The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.
Tipo de estudio
Intervencionista
Inscripción (Actual)
26
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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Goiás
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Goiania, Goiás, Brasil
- GSK Investigational Site
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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 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
EXCLUSION CRITERIA:
- The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
- History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
- Hypo or hypertension of any etiologic that needs pharmacologic treatment;
- The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;
- Has history of alcohol or drugs abuse;
- History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
- Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,
- Pregnancy or breastfeeding,
- Smoking;
- Use of regular medication within 4 weeks prior to study iniciation;
- Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
INCLUSION CRITERIA:
- Age between 18 and 50 years;
- Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
- Good health conditions;
- Obtain the Informed Consent's signed.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Avandamet test product
Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2
|
Avandamet test product
|
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Comparador activo: Avandamet reference product
Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2
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Avandamet reference product
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUC0-t of Rosiglitazone Maleate
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
Cmax of Rosiglitazone Maleate
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-infinity of Rosiglitazone Maleate
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-t of Metformin Hydrochloride
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-infinity of Metformin Hydrochloride
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
Cmax of Metformin Hydrochloride
Periodo de tiempo: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
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 (Actual)
24 de noviembre de 2009
Finalización primaria (Actual)
6 de diciembre de 2009
Finalización del estudio (Actual)
6 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2010
Primero enviado que cumplió con los criterios de control de calidad
17 de marzo de 2011
Publicado por primera vez (Estimar)
8 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
14 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Metformina
- Rosiglitazona
- Ácido maleico
Otros números de identificación del estudio
- 114040
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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