NCT04067791已完成1 期
A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
研究概览
简要总结
A study comparing the pharmacokinetics of prolonged-release melatonin versus standard, immediate-release melatonin. Multiple blood draws over a 10-hour period will be analysed to determine the area under the curve, time to peak concentration, peak concentration, absorption rate constant, elimination rate constant, absorption half-life, and elimination half-life. Vital signs, hematology parameters, clinical chemistry parameters, and incidence of adverse events are also analysed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males between 18 and 65 years of age at screening
- •BMI between 18.5 to 29.9 kg/m2, inclusive
- •Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include: e. Non-hormonal intrauterine devices f. Double-barrier method g. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) h. Vasectomy of partner at least 6 months prior to screening
- •Male participants must agree to the use of condoms unless partner is using an acceptable form of female contraception as defined in Inclusion #3 or a form of hormonal birth control during the study treatment period and for at least 7 days after completion of the study
- •Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 8 hours of sleep for at least 3 weeks
- •Agrees to maintain current sleep schedule throughout study
- •Agrees to maintain current level of physical activity and diet throughout the study
- •Agrees to comply with all study procedures
- •Agrees to consume standardized meals during Visits 2 and 3
- •Agrees to avoid caffeine intake 24 hours prior to Visits 2 and 3
- •Agrees to avoid alcohol intake 24 hours prior to Visits 2 and 3
- •Healthy as determined by medical history, laboratory results, and physical exam as assessed by QI
- •Agrees to provide informed written consent
排除标准
- •Women who are pregnant, breastfeeding or planning to become pregnant during the course of the trial
- •Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients, or the ingredients in the standardized meals
- •Current use of hormonal contraceptives
- •Previous diagnosis of a sleep disorder or use of continuous positive air pressure (C-PAP)
- •Registered with the Canadian National Institute for the Blind (CNIB) and considered as legally blind
- •Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks
- •Travel across 1 or more time zones in the last 2 weeks and/or is anticipating more travel
- •Currently experiencing vivid nightmares or sleepwalking
- •Diagnosis of any pineal gland abnormalities or have undergone pinealectomy
- •Current or history of any significant diseases of the gastrointestinal tract
- •Unstable metabolic disease or chronic diseases as assessed by the QI
- •Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Type I or Type II diabetes
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- •Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable
- •Individuals with an autoimmune disease or are immune-compromised
- •Verbal confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- •Verbal confirmation of an HIV-, Hepatitis B- and/or C-positive diagnosis
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
- •Major surgery in the past 3 months or individuals who have planned surgery, that may impact the outcomes of the study, during the course of the trial. Participants will be considered on a case-by-case basis by the QI
- •Blood/bleeding disorders as determined by laboratory results
- •An acute gout attack within the past 3 months
- •Current use of prescribed medications listed in the con meds section
- •Current use of over-the-counter medications, supplements, foods and/or drinks listed in the con meds section
- •Use of medical marijuana
- •Use of recreational marijuana unless willing to undergo 1-month washout
- •Use of tobacco products within 1-year of baseline
- •Alcohol or drug abuse within the last 12 months
- •High alcohol intake (average of >2 standard drinks per day or >10 standard drinks per week)
- •Clinically significant abnormal laboratory results at screening as assessed by the QI
- •Blood donation within the past 6 months will be assessed on a case by case basis by the QI depending on volume and frequency of donation, and laboratory parameters
- •Plans to donate blood during the study or within 56 days for males and 84 days for females, the last study visit
- •Participation in other clinical research trials 30 days prior to randomization
- •Individuals who are unable to give informed consent
- •Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
结局指标
主要结局
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption half-life
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the area under the curve (AUC 0-10h)
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the time to peak concentration (tmax)
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption rate constant
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the peak concentration (Cmax)
时间窗: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination half-life
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (2)
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