Paxil CR Bioequivalence Study Brazil
Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for Both Genders.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fasted administration in healthy volunteers for both genders.
The study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).
The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not restrictions regarding the ethnic group.The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each fasting period. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30110-014
- GSK Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
EXCLUSION CRITERIA:
- hypersensitivity to the study drug or to compounds chemically related;
- history of serious adverse events;
- concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
- History of liver, heart, gastrointestinal or renal illness;
- ECG findings not recommended according to the investigator judgement;
- The volunteer ingests more than 5 cups of coffee or tea a day.
INCLUSION CRITERIA:
- Man and woman (since they are not pregnant or breastfeeding);
- age between 18 and 40 years;
- non-smoker and not addict;
- mass index between 18,5 and 27;
- good health conditions or without significant illness, by judgement of a legally qualified professional;
- sign the informed consent.
Plan de estudios
¿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: Paxil CR Reference
Reference drug administration followed by test drug administration
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Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
|
|
Comparador activo: Paxil CR Test
Test drug administration followed by Reference drug administration
|
Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area Under the Curve_steady-state
Periodo de tiempo: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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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_steady-state (ss) is the area under the curve during the steady-state period.
The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanogram; h, hour; ml, milliliter.
ng.h/ml, nanograms per hour per milliliter.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmin_steady-state
Periodo de tiempo: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state.
Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmax_steady-state
Periodo de tiempo: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
|
Cmax_steady-state (ss) is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state.
Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 113939
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