Pharmacokinetics and Bioequivalence of Levomilnacipran Hydrochloride Sustained Release Capsules in Beagle Dogs / 中国药学杂志
Chinese Pharmaceutical Journal
; (24): 128-132, 2020.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-857799
Biblioteca responsável:
WPRO
ABSTRACT
OBJECTIVE:
To evaluate the pharmacokinetics and bioequivalence of levomilnacipran hydrochloride sustained release capsules in Beagle dogs.METHODS:
An open, randomized,two-periods trial design was used. HPLC method was established to determine levomilnacipran hydrochloride in plasma samples of beagle dogs. Pharmacokinetic parameters and bioequivalence were evaluated.RESULTS:
The pharmacokinetic parameters of levomilnacipran hydrochloride after oral adminstration of test or reference preparations were as follows ρmax were (394.06±18.22), (384.88±25.65) ng•mL-1; AUC0-72 h were (5 903.86±107.51), (5 396.63±62.63) ng•h•mL-1; AUC0-∞ were (6 325.90±158.88), (6 091.14±121.35) ng•h•mL-1, respectively. The relative bioavailability of F0-72 h(%) and F0-∞(%) of the test/reference formulation were 109.40%, 103.85%; the 90% CIs for the test/reference ratio of ρmax, AUC0-72 h, and AUC0-∞ were 75.11% to 129.61%, 99.35% to 119.44%, and 89.90% to 117.78%, respectively.CONCLUSION:
The RP-HPLC method is simple, efficient and accurate which can be used for the determination of levomilnacipran hydrochloride plasma concentration. The test capsules are bioequivalent to the reference capsules.
Texto completo:
Disponível
Base de dados:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2020
Tipo de documento:
Artigo