- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00870571
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fed Conditions.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers under FedConditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Quebec
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Saint-Laurent, Montreal, Quebec, Canadá, H4R 2N6
- MDS Pharma Services
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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:
Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male or female volunteers, 18-55 years of age;
- Subject will be non-smokers or moderate smokers (less than 10 cigarettes a day) for at least 3 months.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 14 days following the last dose or be using one of the following acceptable birth control methods:
- surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- IUD in place for at least 3 months.
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study, and for 14 days following the last dose.
- surgical sterilization of the partner (vasectomy for 6 months minimum).
hormonal contraceptives for at least 3 months prior to the first dose of the study and for 14 days following the last dose.
Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
- Give voluntary written informed consent to participate in the study.
Exclusion Criteria:
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers.
- Female subjects who are pregnant or lactating.
- SUbjects who tested positive at screening for HIV, HbsAg or HeV.
- Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
- Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
- Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
- Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood In 14 days; 1500 mL of blood in 160 days; 2500 mL of blood In 1 year.
- Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: A
AMLODIPINA (como BESILATO) TABLETAS 10 mg, dosis única
|
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD.
formulated products under fed conditions
Otros nombres:
|
Comparador activo: B
NorvasC® 10 mg Tablets, single dose
|
B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Velocidad y extensión de la absorción
Periodo de tiempo: 72 horas
|
72 horas
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gaetano Morelli,, MD, MDS Pharma Services
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
- 24309
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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