Melatonin BioavailabilityNCT04574141
Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
A study testing a prolonged release tablet and a spray containing melatonin in people with Melatonin Bioavailability, run by PiLeJe at 1 site in France.
Trial summary
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Melatonin Bioavailability
- What is being tested?
- a prolonged release tablet and a spray containing melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2020to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between the ages of 18 and 45,
- In good general health, i.e., free of chronic conditions and not taking medication at the time of inclusion and/or long-term,
- Over 70 kg and with a body mass index between 18.5 and 24.9,
- Able and willing to participate in the research by complying with the procedures of the protocol, in particular concerning the taking of the product under study and the performance of sequential blood tests,
- Having freely signed the consent form after adequate information on the proposed study, in accordance with Good Clinical Practice and after submission of the information leaflet,
- Affiliated to a social security scheme or similar.
Who cannot join
- Smoker,
- Drug addict,
- Subject with an alcohol consumption of more than 2 glasses per day,
- Taking a drug treatment or melatonin or a product containing melatonin within 48 hours prior to a kinetics visit,
- Known organic or functional abnormality of the urinary tree,
- Any medical condition that would involve a change in melatonin metabolism:
Show all 20Show fewer
- Drug intake: Fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, carbamazepine and rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,
- Subject assessed as "moderately" or "definitely" evening type,
- Known hypertension (>140/90),
- Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
- Wuth a sleep disorder,
- Thyroid dysfunction, hyperglycemia or anemia judged to be clinically significant by the investigator,
- Blood donation within one month prior to inclusion,
- A known organic or psychological abnormality (including a history of severe depression) that may bias the results of the study as judged by the investigator,
- Workers with atypical working hours (night work, staggered working hours),
- Known allergy or intolerance to any of the components of the product,
- Psychological or linguistic inability to understand and sign informed consent,
- Participant in another interventional clinical trial or during a period of exclusion from a previous clinical trial,
- Under legal protection (guardianship, curatorship) or deprived of his rights as a result of the administrative or judicial decision,
- Subject who has reached the maximum threshold for compensation for research provided for in the regulations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
- Conditions
- Melatonin Bioavailability
- Being tested
- a prolonged release tablet and a spray containing melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a prolonged release tablet and a spray containing melatoninDietary supplement
prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.
| Study group | Role | What they receive |
|---|---|---|
| spray before tablet | Experimental | Not described Receives: Dietary Supplement: a prolonged release tablet and a spray containing melatonin |
| tablet before spray | Experimental | Not described Receives: Dietary Supplement: a prolonged release tablet and a spray containing melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of the plasma melatonin concentration
the change in plasma melatonin concentration
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary outcomes (20)
evolution of the plasma concentration of 6-sulfatoxymelatonin
the change in plasma 6-sulfatoxymelatonin concentration
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
evolution of the urinary concentration of 6-sulfatoxymelatonin
the change in urinary 6-sulfatoxymelatonin concentration
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
evolution of the salivary concentration of melatonin
the change in salivary melatonin concentration
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
adverse events
adverse events
Measured: during study participation, maximum 45 days
plasma melatonin AUC
Area Under the Curve of plasma melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin AUC
Area Under the Curve of plasma 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin AUC
Area Under the Curve of urinary 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin AUC
Area Under the Curve of salivary melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin Cmax
Peak concentration of plasma melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin Cmax
Peak concentration of plasma 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin Cmax
Peak concentration of urinary 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin Cmax
Peak concentration of salivary melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin Tmax
Time take to reach Cmax of plasma melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin Tmax
Time take to reach Cmax of plasma 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin Tmax
Time take to reach Cmax of urinary 6-sulfatoxymelatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin Tmax
Time take to reach Cmax of salivary melatonin
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin half life
time required for the concentration of plasma melatonin to decrease to half of its starting dose
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin half life
time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin half life
time required for the concentration of urinary 6-sulfatoxymelatonin to decrease to half of its starting dose
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin half life
time required for the concentration of salivary melatonin to decrease to half of its starting dose
Measured: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start13 Jul 2020
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melatonin BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Claustrat, Study director, PiLeJe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574141
- Sponsor's protocol ID
- Pil-Clin-Melat-020
- Status last verified
- Mar 2021
- First submitted
- 27 Jul 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing
Publications
Ait Abdellah S, Raverot V, Gal C, Guinobert I, Bardot V, Blondeau C, Claustrat B. Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers. Drugs R D. 2023 Sep;23(3):257-265. doi: 10.1007/s40268-023-00431-9. Epub 2023 Jul 12.
PubMed 37438493
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
- ClinicalTrials.gov ID
- NCT04574141
- Acronym / sponsor ID
- Pil-Clin-Melat-020
- Conditions
- Melatonin Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spray before tablet | Experimental | Dietary Supplement: a prolonged release tablet and a spray containing melatonin |
| tablet before spray | Experimental | Dietary Supplement: a prolonged release tablet and a spray containing melatonin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male between the ages of 18 and 45,
- In good general health, i.e., free of chronic conditions and not taking medication at the time of inclusion and/or long-term,
- Over 70 kg and with a body mass index between 18.5 and 24.9,
- Able and willing to participate in the research by complying with the procedures of the protocol, in particular concerning the taking of the product under study and the performance of sequential blood tests,
- Having freely signed the consent form after adequate information on the proposed study, in accordance with Good Clinical Practice and after submission of the information leaflet,
Key exclusion criteria (20 listed)
- Smoker,
- Drug addict,
- Subject with an alcohol consumption of more than 2 glasses per day,
- Taking a drug treatment or melatonin or a product containing melatonin within 48 hours prior to a kinetics visit,
- Known organic or functional abnormality of the urinary tree,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a prolonged release tablet and a spray containing melatoninprolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays. | Dietary supplement | spray before tablet, tablet before spray |
Primary outcome
evolution of the plasma melatonin concentration
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
the change in plasma melatonin concentration
20 secondary outcomes
evolution of the plasma concentration of 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
evolution of the urinary concentration of 6-sulfatoxymelatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
evolution of the salivary concentration of melatonin
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
adverse events
Time frame: during study participation, maximum 45 days
plasma melatonin AUC
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin AUC
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin AUC
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin AUC
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin Cmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin Cmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin Cmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin Cmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin Tmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin Tmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin Tmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin Tmax
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma melatonin half life
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
plasma 6-sulfatoxymelatonin half life
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
urinary 6-sulfatoxymelatonin half life
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
salivary melatonin half life
Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 37438493Ait Abdellah S, Raverot V, Gal C, Guinobert I, Bardot V, Blondeau C, Claustrat B. Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers. Drugs R D. 2023 Sep;23(3):257-265. doi: 10.1007/s40268-023-00431-9. Epub 2023 Jul 12.
- Individual participant dataSharing planned: No. no sharing
Related trials for Melatonin Bioavailability
Not yet recruitingPhase 3
Melatonin vs Midazolam in Children Undergoing Tonsillectomy
Emergence Delirium, Anesthesia, Child
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Claustrat study director
PiLeJe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a prolonged release tablet and a spray containing melatonin in people with Melatonin Bioavailability, run by PiLeJe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of the plasma melatonin concentration (time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.