Evaluating the pharmacokinetics and safety of blonanserin tablets and Lonasen®: a randomized, open-label, two-period, two-sequence, self-crossover phase I clinical trial

Evaluating the pharmacokinetics and safety of blonanserin tablets and Lonasen®: a randomized, open-label, two-period, two-sequence, self-crossover phase I clinical trial

ObjectiveThis study evaluated the pharmacokinetic and safety profiles of generic and original blonanserin tablets under fasting and postprandial conditions, and the bioequivalence of two formulations to obtain sufficient evidence for abbreviated new drug application.MethodsA randomized, open-label,...

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Bibliographic Details
Main Authors: Bo Qiu, Haojing Song, Xue Sun, Congyang Ding, Runxuan Du, Wanjun Bai, Zhanjun Dong
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Pharmacology
Subjects:
blonanserin
schizophrenia
bioequivalence
pharmacokinetics
safety
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2024.1511214/full
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