NL-OMON50156已完成不适用
A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Bedtime Dosing of JZP-324 (Extended Release Oxybate) for Oral Suspension in Healthy Subjects - JZP-324 (Extended Release Oxybate) bedtime dosing study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy male or female subjects aged 18 to 45 years, inclusive.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, with a minimum
- •body weight of
- •3. Good general health as determined by the investigator through medical
- •history, physical
- •examination, electrocardiogram (ECG), vital signs, and laboratory tests at
- •Screening and baseline
- •(Day -1).
- •4. Negative screens for human immunodeficiency virus antibodies (HIV-Ab),
- •hepatitis B surface
- •antigens (HBsAg), hepatitis C virus antibodies (HCV-Ab), hepatitis A IgM
- •antibodies (Hep A
- •IgM - Ab), and no clinical history related to these infections.
- •5. Negative urine drug and urine alcohol screens and negative serum pregnancy
- •tests (for female
- •subjects) at Screening and baseline (Day -1).
- •(For the complete overview of the Main Inclusion Criteria see the protocol)
排除标准
- •1. Has a clinically significant unstable medical abnormality, chronic disease,
- •or history or presence
- •of significant neurological (including seizure and cognitive disorders) or
- •psychiatric disorder (incl. depression suicidality, schizophrenia etc.),
- •hepatic, renal, endocrine, cardiovascular (including hypertension),
- •gastrointestinal, pulmonary, or metabolic disease or any other abnormality that
- •could interfere with the pharmacokinetic evaluation of the study drug.
- •2. Has a history or the presence of gastrointestinal (including peptic ulcer),
- •hepatic, or renal disease
- •or other condition known to interfere with the absorption, distribution,
- •metabolism, or excretion of drugs.
- •3. Is a female subject who is pregnant or plans to become pregnant during the
- •study, nursing, or
- •4. Has any severe drug allergy or a history of allergic or severe adverse
- •reactions (asthma, urticaria)
- •or intolerance to oxybate products (eg. Xyrem), gamma-hydroxybutyrate (GHB), or
- •any components of the dosage forms.
- •5. Has a history of substance (drug or alcohol) abuse within the last 2 years,
- •known drug dependence, or positive test for drugs of abuse.
- •(For the complete overview of the Main Inclusion Criteria see the protocol)
研究者
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