对精神分裂症或精神分裂症患者的长效帕利佩里多中心生物可用性研究
Thalita Martins da Silva1, Débora Renz Barreto Vianna2, Jessica Meulman1
1Department of Operations, Clinical Research Unit, Adium S.A., São Paulo, São Paulo,Brazil.
Journal of clinical psychopharmacology
|September 3, 2025
概括
一种新的长效可注射帕利皮酸盐配方Vegapali与参考药物具有生物等价性. 这证实了它在精神分裂症治疗中的有效性和安全性,改善了患者获得LAI抗精神病药物的机会.
科学领域:
- 药理学和制药科学
- 精神病学与心理健康
- 临床研究
背景情况:
- 精神分裂症治疗不坚持口服抗精神病药物导致复发和增加医疗费用.
- 长效注射抗精神病药物 (如帕利皮酸盐) 可以减轻复发的风险.
- 对LAI抗精神病药物的生物等效配方可以提高治疗的可用性,同时保持安全性和有效性.
研究的目的:
- 为了评估一种可延长释放的注射悬浮剂 paliperidone palmitate (PP-ERIS) 的生物等价性,Vegapali
- 在精神分裂症或精神分裂症患者中,将Vegapali与参考配方Invega Sustenna进行比较.
主要方法:
- 这是一项为期7个月的多中心随机开放式并行药理学 (PK) 研究.
- 每月注射测试剂 (Vegapali) 或参考剂.
- 确定了平稳状态的PK参数 (Cmax,ss和AUCτ,ss). 在几何平均比率为80.00% - 125.00%的情况下,确认了生物等价性.
主要成果:
- 药物动力学分析证实了生物等价性,Cmax,ss和AUCτ,ss的90% CI在80. 00% - 125. 00%的范围内.
- 这两种配方都显示出可比的全身暴露.
- 不良事件发生率与帕利皮里顿棕酸盐已知的安全性概况一致.
结论:
- 测试配方Vegapali与参考帕利皮酸盐的LAI具有生物等价性.
- 维加帕利是一种可行的LAI治疗方案,可确保治疗效果相等.
- 这一发现扩大了治疗精神分裂症的有效途径.
相关概念视频
Psychosis: Goals of Pharmacotherapy
209
Antipsychotic drugs are a crucial treatment method for acute and chronic psychoses, bipolar illness, and behavioral disorders. The selection of these drugs depends on several factors, including the state of the disease, clinical judgment, possible drug interactions, and the patient's sensitivity to adverse effects. In immediate scenarios, such as delirium and dementia, short-term treatment with low doses of high-potency typical or atypical agents can effectively manage symptom exacerbation.
209
Bioavailability: Overview
3.1K
Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
3.1K
Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
293
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
293
Psychosis and Antipsychotic Drugs: Overview
453
The term "psychosis" refers to a spectrum of mental disorders characterized by abnormal thoughts, perceptions, and behaviors. It can manifest as mood disorders, dementia, delirium with psychotic features, substance-induced psychosis with psychotic features, brief psychotic disorder, delusional disorder, schizoaffective disorder, and schizophrenia. Among all these disorders, schizophrenia is the most common psychotic disorder, affecting 1% of the worldwide population. Psychotic...
453
Nonlinear Pharmacokinetics: Bioavailability and Protein-Drug Binding
273
When a drug follows nonlinear pharmacokinetics, its bioavailability, the amount of the drug that reaches the systemic circulation, can change with different doses. This is due to the presence of a saturable pathway. The pathway becomes saturated as the drug concentration increases, decreasing the absorption rate. Consequently, the drug's bioavailability may be lower than expected at higher doses.
To quantify the extent of bioavailability, pharmacologists often use a parameter called .
To quantify the extent of bioavailability, pharmacologists often use a parameter called .
273
Analysis of Population Pharmacokinetic Data
382
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
382


