Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection

Janssen Research & Development, LLC0 个研究点目标入组 31 人开始时间: 2012年2月最近更新: 2013年4月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Janssen Research & Development, LLC
入组人数: 31
主要终点: Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.

详细描述

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Body mass index (weight [kg]/height2 [m]2) between 17 and 35 kg/m2 (inclusive), and body weight not less than 50 kg
•If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
•If a woman, must have negative pregnancy test at screening
•If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
•Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

排除标准

•History of or current clinically significant medical illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
•Clinically significant abnormal values for laboratorial tests
•Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen), oral contraceptives and hormonal replacement therapy, within 14 days before the study drug administration is scheduled
•Positive test for alcohol or drugs of abuse at screening
•Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)

研究组 & 干预措施

Cohort A: Aripiprazole

Experimental

干预措施: Aripiprazole (Drug)

Cohort B: Quetiapine

Experimental

干预措施: Quetiapine (Drug)

Cohort C: Olanzapine

Experimental

干预措施: Olanzapine (Drug)

Cohort D: Risperidone

Experimental

干预措施: Risperidone (Drug)

Cohort E: Paliperidone

Experimental

干预措施: Paliperidone (Drug)

结局指标