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Evaluation of the effects of formulation food or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study

机译：评价制剂食物或质子泵抑制剂对健康志愿者中格拉斯迪布（PF-04449913）药代动力学的影响：一项随机I期研究

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PurposeTo demonstrate the bioequivalence of the planned maleate salt-based commercial glasdegib tablet formulation [International Council for Harmonization (ICH) glasdegib] to the clinical di-hydrochloride (di-HCl) salt-based glasdegib formulation (di-HCl glasdegib). Additionally, to estimate the effects of a high-fat, high-calorie meal and proton-pump inhibitor (PPI) on the pharmacokinetics of ICH glasdegib.

机译：目的证明计划中的马来酸盐为基础的商品格拉斯德布片剂[国际协调委员会（ICH）格拉斯德布]与临床二盐酸盐（di-HCl）盐基格拉斯德布制剂（di-HCl glasdegib）的生物等效性。另外，为了评估高脂，高热量膳食和质子泵抑制剂（PPI）对ICH glasdegib药代动力学的影响。

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期刊名称 Springer Open Choice
作者
Naveed Shaik; Brian Hee; Hua Wei; Robert R. LaBadie;
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作者单位

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年(卷),期 -1(83),3
年度 -1
页码 463–472
总页数 10
原文格式 PDF
正文语种
中图分类外科学;
关键词
PF-04449913 Glasdegib Pharmacokinetics Food effect Formulation Proton-pump inhibitor;

机译：PF-04449913;Glasdegib;药代动力学;食物效应;制剂;质子泵抑制剂;

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1. Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study [J] . Shaik Naveed, Hee Brian, Wei Hua, Cancer chemotherapy and pharmacology. . 2019,第3期

机译：评估制剂，食物或质子泵抑制剂对健康志愿者（PF-04449913）的药代动力学的影响：我研究的随机阶段
2. Evaluation of the effect of new formulation, food, or a proton pump inhibitor on the relative bioavailability of the smoothened inhibitor glasdegib (PF-04449913) in healthy volunteers [J] . Nagdeep Giri, Lisa H. Lam, Robert R. LaBadie, Cancer chemotherapy and pharmacology. . 2017,第6期

机译：评估新配方，食品或质子泵抑制剂对健康志愿者（PF-04449913）的相对生物利用度的影响
3. Evaluation of the effect of food and ketoconazole on the pharmacokinetics of the smoothened inhibitor PF-04449913 in healthy volunteers [J] . ShaikM.N., LaBadieR.R., RudinD., Cancer chemotherapy and pharmacology. . 2014,第2期

机译：评价食物和酮康唑对平滑志愿者PF-04449913在健康志愿者中的药代动力学的影响
4. A Phase I, Double-Blind, Randomized, Dose Escalating Crossover Study ofan Oral Formulation of Human Growth Hormone in Healthy Male Volunteers [C] . Steven M. Dinh, Puchun Liu, Ehud Arbit, Controlled Release Society annual meeting . 2004

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5. Cooking Healthy, Eating Smart (CHES): Evaluating the feasibility of using volunteers to deliver nutrition and food safety education to rural older adults. [D] . Getty, Morgan. 2014

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6. A Phase I Randomized Double-Blind Placebo-Controlled Single Ascending Dose Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance Pharmacokinetics of Jaktinib a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers [O] . Jingrui Liu, Binhua Lv, Hewen Yin, 2020

机译：I期随机双盲安慰剂控制单一升序剂量多个上升剂量和食物效应研究以评估jaktinib的耐受性药代动力学健康中国志愿者的新选择性Janus激酶抑制剂
7. Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study [O] . Naveed Shaik, Brian Hee, Hua Wei, 2018

机译：评估制剂，食物或质子泵抑制剂对健康志愿者（PF-04449913）的药代动力学的影响：我研究的随机阶段

Evaluation of the effects of formulation food or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study

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