ACTRN12615001168549已完成1 期
An Open-label, Randomized, Two-period, Cross-over Study to Assess the Bioavailability, Safety, and Tolerability of the Dexmedetomidine Transdermal System (DMTS) versus Intravenous Dexmedetomidine in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Healthy male or female subjects 18 to 45 years of age, inclusive.
- •2.Subjects must be non-smokers, as defined by cessation of smoking and use of all other tobacco and nicotine products (including chewing tobacco, snuff, e-cigarettes, nicotine patches, etc.) for at least 1 year prior to screening.
- •3.Body mass index (BMI) within the range of 18 to 29 kg/m2, inclusive, and a weight of at least 50 kg.
- •4.Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject’s ability to wear the investigational product at any of the application sites for the specified duration of treatment.
- •5.Female subjects of childbearing potential must be practicing abstinence or using and willing to continue using a medically acceptable form of contraception for at least
- •1 month prior to screening (at least 3 months for oral contraceptives) and for at least 30 days after the last study drug administration.
- •6.Female subjects must have a negative serum pregnancy test at screening and prior to dosing.
- •7.Must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
- •8.Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
- •9.Must be willing and able to abide by all study requirements and restrictions.
排除标准
- •1.A history or presence of drug or alcohol dependence (excluding caffeine), including subjects who have ever been in a drug rehabilitation program based on medical history of the past 10 years.
- •2.Clinically significant abnormalities as judged by the investigator or designee and determined by physical examination (PE), medical history, 12-lead electrocardiogram
- •(ECG), vital signs, laboratory values, including serum kidney and liver function tests.
- •3.Presence of postural hypotension (determined through examination by the investigator or designee), or recent history of severe dizziness or fainting due to postural hypotension on standing.
- •4.Subjects with a history of seizures, asthma, or obstructive pulmonary disease.
- •5.Presence or history of any of the following disorders that are deemed clinically significant by the investigator or designee: a psychiatric disorder (including suicidal ideation and behavior), organic brain disorder, or seizure disorder.
- •6.Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including ulcers or gastrointestinal bleeding), endocrine, immunologic, dermatologic, neurologic, oncologic, psychiatric disease, or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- •7.Abnormality (eg, scar, tattoo) or unhealthy skin (eg, burns, wounds) at the application site, according to examination by the investigator at screening, admission to the clinic, or prior treatment period of the study.
- •8.An existing chronic skin disease or history of skin disease at the application site within the 30 days prior to screening.
- •9.Use of any drugs containing estrogens within 30 days prior to the first study drug administration and throughout the study.
研究者
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