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Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects.

Authors :
Li, Ting
Sun, Feifei
Liu, Yanping
Su, Lingping
Shi, Ping
Li, Xin
Liu, Shuqin
Wang, Chenjing
Shen, Linjing
Cao, Yu
Wang, Shumin
Source :
Clinical Pharmacology in Drug Development; Dec2022, Vol. 11 Issue 12, p1474-1480, 7p
Publication Year :
2022

Abstract

Eldecalcitol is a novel active vitamin D3 1,25(OH)2D3 derivative used in the treatment of osteoporosis. To investigate and compare the pharmacokinetic and bioequivalent profiles of two eldecalcitol soft capsule formulations at a single dose of 0.75 µg in healthy Chinese volunteers, we conducted a randomized single‐dose, open‐label, two‐period crossover study under fasting and fed conditions. Eligible subjects were randomly assigned to receive reference eldecalcitol soft capsules or test capsules in the first treatment period and to receive another formulation in the second period. Serial blood samples were collected for pharmacokinetic analysis. Adverse events were recorded. In total, 28 healthy subjects were enrolled in the fasting trial and 30 subjects were enrolled in the fed trial. The geometric mean ratios of the test formulation to the reference formulation for Cmax, AUC0‐t, and AUC0‐∞ were 94.2%, 94.0%, and 103.3%, respectively, under fasting conditions and 100.1%, 97.3%, and 96.0%, respectively, under fed conditions. No severe adverse events were observed. The results showed that the test and reference eldecalcitol formulations were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
2160763X
Volume :
11
Issue :
12
Database :
Complementary Index
Journal :
Clinical Pharmacology in Drug Development
Publication Type :
Academic Journal
Accession number :
160509338
Full Text :
https://doi.org/10.1002/cpdd.1159