Pharmacokinetics of Melatonin Niosomes Oral Gel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration
研究概览
简要总结
Melatonin is an endogenous hormone. It is able to promote nighttime sleeping and could induce sleep at daytime in adult and children with the nonpainful diagnostic procedure. However, previous formulation had problems of unstability of product and low oral bioavailability. Melatonin niosomes oral gels are formulated in order to overcome the problem of drug absorption and stability. This study is a randomized, double-blind, three phase crossover design in 15 male volunteers. Melatonin niosomes oral gel will be applied at doses 2.5, 5, and 10 mg with 7 days washout for each period. The pharmacokinetics data, sleep induction effect, and adverse event will be determined.
详细描述
This study will determine the pharmacokinetics, sleep induction effect, and adverse event after apply melatonin niosomes (MN) oral gel 2.5, 5, and 10 mg per dose in 15 male healthy volunteers. The pharmacokinetic parameters include maximum plasma concentration (Cmax), area under the curve (AUC), time to peak concentration (Tmax), elimination half-life (t1/2). Sleep induction will be determined as sleep onset and duration after use MN oral gels using actigraph and behavior observation. A polysomnography using electrode placement derive from multiple sleep latency test (MSLT) protocol will be used in some subjects. Adverse event will be evaluated by investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 18-30 years
- •body mass index 18.5-25 kg/m2
- •general good health and no underlying disease by physical examination and laboratory testing (blood urea nitrogen, creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, complete blood count)
- •provide signed informed consent for study participation
排除标准
- •history of allergies to melatonin products
- •use of any drugs, vitamins, or supplements within 30 days before participation
- •smoke or alcohol consumption within 1 week before participation
- •blood or plasma donation within 30 days before participation
研究组 & 干预措施
melatonin niosomes oral gel 2.5 mg
apply onto oral mucosa as single use
干预措施: Melatonin (Drug)
melatonin niosomes oral gel 5 mg
apply onto oral mucosa as single use
干预措施: Melatonin (Drug)
melatonin niosomes oral gel 10 mg
apply onto oral mucosa as single use
干预措施: Melatonin (Drug)
结局指标
主要结局
Concentration-time profile after 2.5, 5, and 10 mg Melatonin niosomes (MN) oral gel single dose administration
时间窗: 0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min after MN oral gel administration
Blood sampling
次要结局
- Sleep induction effect (sleep onset latency, total sleep time, and wake after sleep onset) after 2.5, 5, and 10 mg MN oral gel single dose administration(0-480 min after MN oral gel administration)
研究者
Supawan Laohasiriwong
Department of Otorhinolaryngology, Faculty of Medicine
Khon Kaen University