A Phase 1 interventional study of Melatonin 25 mg in Melatonin, Pharmacokinetics and Safety, sponsored by Dennis Bregner Zetner. Completed at 1 site in Denmark. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Dennis Bregner Zetner · Phase 1, Interventional, and Basic science
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.
Dennis Bregner Zetner is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Intravenous administration, making it possible to calculate bioavailability for other routes of administration
Drug: Melatonin 25 mg
Rectal administration of melatonin
Drug: Melatonin 25 mg
Intravesical administration of melatonin
Drug: Melatonin 25 mg
Vaginal administration of melatonin
Drug: Melatonin 25 mg
Transdermal administration of melatonin
Drug: Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.
Plasma concentration of melatonin
Plasma concentration of melatonin
Time frame: 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
Plasma concentration of melatonin
Plasma concentration of melatonin
Time frame: 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
Karolinska Sleepiness Scale
Scale which evaluates tiredness of participants
Time frame: 0 minutes, once hourly for 8 hours, and again at 24 hours
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.
Time frame: 0 minutes, once hourly for 8 hours, and again at 24 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Dennis Bregner Zetner