Influence of dose interval on the pharmacokinetics of both unbound and total fractions of clozapine and norclozapine in psychiatric patients in the Netherlands - INPUT study

Albert Schweitzer hospital0 个研究点目标入组 50 人开始时间: 2018年3月29日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•?Age =18 – 65 years
•?Clozapine use BID or OID
•?Capacity to speak and read the Dutch language.
•?Mental competency and decisional capacity with regard to participation in the current study
•?Absence of active suicidality
•?Clozapine use in ‘steady state’ (i.e. same dose and frequency for =7 days)
•?Signed Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•?‘inbewaringstelling’ (IBS)
•?‘rechterlijke machtiging’ (RM)
•?Pregnancy (if known)
•?Initiation, cessation or dose change of the following co-medication within 7 days prior to blood sampling:
•oFluvoxamine
•oHormonal anti-conceptive,
•oCiprofloxacin,
•oPhenytoin,
•oValproic acid,
•oCarbamazepine
•oRifampicin.
•?Acute inflammation / infection (derived from having fever (i.e. body temperature >38.0 degrees Celsius and/or using an antibiotic at time of blood sampling).
•?Smoking (of tobacco containing products) initiation or cessation < 7 days before participation

发起方