Bioequivalence Study of Rivastigmine 6 mg Capsules (Single Dose) in Healthy Volunteers.
Am J Alzheimers Dis Other Demen
; 32(6): 360-366, 2017 Sep.
Article
en En
| MEDLINE
| ID: mdl-28670911
ABSTRACT
OBJECTIVE:
To assess the bioequivalence of generic formulation of rivastigmine (test) and Exelon (reference).METHODS:
This randomized, open-label, 2-period, single-dose, 2-treatment, 2-sequence, crossover study was conducted in 40 healthy men under fed condition. Participants were randomized to receive a single dose of Exelon or rivastigmine capsule.RESULTS:
A total of 31 participants completed the study. Area under the concentration-time curve from time zero to time t (AUC0- t) and area under the concentration-time curve from time zero to infinity (AUC0-∞) for Exelon (mean [standard deviation], h·ng/mL) were 126.40 (56.95) and 129.46 (59.94), respectively, while they were 122.73 (43.46) and 125.08 (45.39) for rivastigmine. Geometric mean ratios of rivastigmine/Exelon were 99.17% for AUC0- t, 98.81% for AUC0-∞, and 105% for maximum observed plasma concentration ( Cmax). The 90% confidence intervals (CIs) were 94.14% to 104.46%, 93.77% to 104.12%, and 93.08% to 118.44%, respectively. Both formulations were well tolerated.CONCLUSION:
The generic and reference formulations were bioequivalent, as the 90% CIs for Cmax, AUC0- t, and AUC0-∞ were within the range of 80% to 125%.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Inhibidores de la Colinesterasa
/
Rivastigmina
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Año:
2017
Tipo del documento:
Article