drugset / Trial / NCT03519750
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
Phase 1
Completed
10 enrolled
Dennis Bregner Zetner
Copenhagen University Hospital, Denmark · collabHerlev Hospital · collabRepoCeuticals ApS · collab
Non-randomizedCrossoverOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2018-11-01
- Primary completion
- 2019-02-21
- Completion
- 2019-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 25 mg | Intravenous |
Indications
No indication recorded.