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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pharmavite LLC
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption half-life
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the area under the curve (AUC 0-10h)
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the time to peak concentration (tmax)
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption rate constant
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the peak concentration (Cmax)
Time Frame: 7 days
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination half-life
Time Frame: 7 days
Secondary Outcomes
No secondary outcomes reported