Bioequivalence study of cinacalcet hydrochloride tablets in healthy Chinese volunteers / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
; (12): 171-177, 2023.
Article
ي Zh
| WPRIM
| ID: wpr-1014682
المكتبة المسؤولة:
WPRO
ABSTRACT
AIM:
To evaluate the bioequivalence of cinacalcet hydrochloride tablets in healthy Chinese volunteers.METHODS:
A randomized, open, double-period and crossover trial was conducted, 48 healthy volunteers were administered a single dose of cinacalcet test tablets or reference tablets orally under each fasting and fed condition. The concentration of cinacalcet was determined by validated LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 to study its bioequivalence.RESULTS:
The main pharmacokinetic parameters of test tablets and reference tablets under fasting condition were as follows C
النص الكامل:
1
الفهرس:
WPRIM
اللغة:
Zh
مجلة:
Chinese Journal of Clinical Pharmacology and Therapeutics
السنة:
2023
نوع:
Article