Pharmacokinetics Clinical Trial
Official title:
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
Verified date | April 2019 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 21, 2019 |
Est. primary completion date | February 21, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion criteria: - Healthy female - 20-40 years old - BMI 18-30 Exclusion criteria: - Inability to understand Danish, written or spoken. - Current use of melatonin or other hypnotics/sedatives - Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session) - Breast feeding - Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs) - Mental illness (defined as being in medical treatment) - Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4) - Participation in other clinical trials less than 1 month prior to current study - Night-shift work within the last 14 days prior to study - Planned night-shift work within the study period - Known and diagnosed sleep-disorder (defined as being in current medical treatment) - Plasma hemoglobin <7.8 mmol/L (measured when screening participants) |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Dennis Bregner Zetner | Copenhagen University Hospital, Denmark, Herlev Hospital, RepoCeuticals ApS |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of melatonin | Plasma concentration of melatonin | Baseline, 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours | |
Primary | Plasma concentration of melatonin | Plasma concentration of melatonin | Baseline, 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 48 hours | |
Secondary | Karolinska Sleepiness Scale | Scale which evaluates tiredness of participants | 0 minutes, once hourly for 8 hours, and again at 24 hours | |
Secondary | Simple Reaction Time Test | A simple reaction time test which measures the participants' reaction time; they are looking at a red lamp, and need to react when it changes to green. | 0 minutes, once hourly for 8 hours, and again at 24 hours |
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