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NCT04067791
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
Phase 1 trial testing Prolonged-Release Melatonin in Healthy in 18 participants. Completed in 27 August 2019.
27 August 2019
Quick facts
| Lead sponsor | Pharmavite LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 18 |
| Start date | 1 August 2019 |
| Primary completion | 27 August 2019 |
| Estimated completion | 27 August 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Prolonged-Release Melatonin — full drug profile →
- Immediate-Release Melatonin
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pharmavite LLC — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults.
Mun JG, Wang D, Doerflein Fulk DL, Fakhary M, et al · · 2024 · cited 6× · PMID 37150895 · DOI 10.1080/19390211.2023.2206475
Verify or expand the search:
- PubMed search for NCT04067791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pharmavite LLC trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04067791 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharmavite LLC
- Last refreshed: 9 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04067791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing