在健康的尼日利亚人中对达的非分区和人口药理动力学分析:试点研究
Olayinka A Kotila1,2, David T Ajayi3, Collen Masimirembwa4
1Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria.
British journal of clinical pharmacology
|July 25, 2023
概括
这项研究开发了第一个尼日利亚人达的人口药理动力学 (popPK) 模型. 该模型显示,性别和体重显著影响达普松.
科学领域:
- 药理动力学 药理动力学
- 药学指标 (Pharmacometrics) 是一个指标.
- 药物的新陈代谢和处置
背景情况:
- 达普森广泛用于各种皮肤和非皮肤疾病.
- 尼日利亚人群中缺少达普的人口药理动力学 (popPK) 数据.
- 了解特定人群中达普森的药理动力学对于优化治疗至关重要.
研究的目的:
- 在尼日利亚参与者中开发和描述达的种群药理动力学 (popPK) 模型.
- 为了确定关键的药理动力学参数及其在这个人群中的变异性.
- 调查性别和体重等共变量的对达普药理动学的影响.
主要方法:
- 采用了非分区分析和非线性混合效应建模.
- 从11名尼日利亚参与者那里收集了数据,这些参与者服用了50毫克的达普片.
- 使用了一个带有延迟时间,第一阶段吸收和第一阶段消除的单间模型.
主要成果:
- 关键的药理动力学参数包括Cmax (1.16 ± 0.32μg/mL),Tmax (3.77 ± 2.40小时) 和t1/2z (30.23 ± 11.76小时).
- 种群的药理动力学模型参数估计为:ka (1.78 h−1),V/F (89.25 L) 和Cl/F (1.32 Lh−1).
- 性别与达普森清除 (Cl/F) 有显著关联,体重与分布体积 (V/F) 有显著关联.
结论:
- 开发的单间popPK模型有效地描述了尼日利亚人的达的药理动力学.
- 性别和体重是达普森在这个人群中的倾向的重要决定因素.
- 该模型为尼日利亚患者的个性化达普松剂量策略提供了基础.
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