A Phase I, Open-Label, Randomized, Four Period Crossover Drug Interaction Study to Evaluate the Pharmacokinetic Profiles of VYVANSE™ and ADDERALL XR When Each is Administered Alone and in Combination With the Proton Pump Inhibitor Prilosec OTC™ in Healthy Adult Volunteers

Shire1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2008年9月8日最近更新: 2021年6月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Shire
入组人数: 24
试验地点: 1
主要终点: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

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研究点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 determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy volunteers, age 18 to 45 inclusive at the time of consent.
•Male, or non-pregnant, non-lactating female
•Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening, and a negative urine pregnancy test on Day -1 after checking into the clinic the day before the first dose of investigational product.
•Body Mass Index (BMI) between 20.0 and 30.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
•Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation
•Normal or clinically insignificant Screening ECG findings as assessed by the Investigator.
•Ability to swallow investigational products.

排除标准

•Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.
•Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational products or study procedures.
•Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.
•History of significant anxiety, tension or agitation as assessed by the Investigator.
•History of or current diagnosis of glaucoma.
•History of a seizure disorder (other than infantile febrile seizures), any tic disorder or a current diagnosis and/or known family history of Tourette's Disorder.
•History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
•History of controlled or uncontrolled hypertension or a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
•Known family history of sudden cardiac death or ventricular arrhythmia.
•Currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
•Current use of any medication (including prescription, over the counter [OTC], herbal or homeopathic preparations) with the exception of hormonal replacement therapy or hormonal contraceptives (Current use is defined as use within 14 days of first dose of investigational product).
•Use of any medication known to inhibit or induce the CYP450 enzymes responsible for the metabolism of the investigational products within 14 days of first dose of investigational product.
•Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds or any of the stated ingredients.
•History of alcohol or other substance abuse within the last year.

研究组 & 干预措施

Vyvanse (LDX)

Experimental

干预措施: Lisdexamfetamine Dimesylate (Drug)

Adderall XR (AXR)

Experimental

干预措施: Adderall XR (mixed salts amphetamine) (Drug)

结局指标

主要结局

Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC