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

ABSTRACT: Eldecalcitol is a novel active vitamin D₃ 1,25(OH)₂ D₃ 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 w

SUBMITTER: Li T 

PROVIDER: S-EPMC10087228 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature