Nutrition, HealthyBIOLEMONNCT06949592
Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement
A study testing M_ML in people with Nutrition, Healthy, run by Fytexia at 1 site in Spain.
Trial summary
The objective of this study is to identify phenolic compound biomarkers of the intake of a mixture of Melissa officinalis extract, acerola extract and vitamin B5. This will be done through the study of their bioavailability and nutrikinetics by measuring their plasma concentrations and urinary excretion over 24h by… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- M_ML
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2025to 12 Jun 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between 18 and 60 years old.
- Agree to follow the dietary and exercise guidelines of the study.
- Sign the informed consent form.
- Be able to read, write, and speak Spanish and/or Catalan.
Who cannot join
- Body Mass Index (BMI) <18.5 kg/m² or ≥30 kg/m².
- Presence of intolerances or allergies related to polyphenols or any of the components of the products evaluated, such as acerola, maltodextrin, or Melissa officinalis.
- Use of medication that could affect the study results, including antibiotics, glucocorticoids, steroids, antidepressants (especially selective serotonin reuptake inhibitors (SSRIs), medications used to control sleep or stress, antipsychotics, anticonvulsants, oral contraceptives, beta-blockers, benzodiazepines, and antihypertensives.
- Regular consumption herbal or plant-based supplements. Participants who take multivitamin supplements may still participate in the study, provided they agree to stop taking them for 48 hours before and on the day of the intervention.
- Regular consumption of melatonin supplements. Participants who occasionally take melatonin may be included if they have had at least a one-week washout period since the last dose.
- Presence of disrupted sleep cycle or irregular sleep routines, such as shift workers (night or rotating shifts), or due to external factors such as recent or upcoming travel across time zones, or co-sleeping with a newborn/baby that disrupts sleep.
Show all 20Show fewer
- Report self-perceived psychological stress, meaning they answer "yes" to the question: "Do you consider yourself to be severely stressed?"
- Self-reported trouble sleeping and/or falling asleep.
- To be diagnosed with anemia.
- Active smoker or have quit smoking less than 6 months ago.
- Consumption of alcoholic beverages: Men: 4 or more Standard Drink Units (SDUs)* daily or 28 SDUs weekly; Women: 2 or more SDUs daily or 17 SDUs weekly.
- Presence of liver, kidney, or gastrointestinal disease that may affect compound absorption and/or study results, such as: celiac disease, Crohn's disease, chronic kidney disease, active cancer in any digestive or renal organ, or hepatitis.
- Previous blood extraction and/or donation: ≥200 ml within 1 month prior to study inclusion, or ≥400 ml within 3 months prior to study inclusion.
- Have lost 3 kg or more in the past 3 months.
- Pregnant or planning to become pregnant.
- Currently breastfeeding.
- Unable to comply with the study protocol.
- Currently participating or have participated in a nutritional intervention study involving nutraceuticals or pharmaceuticals within the 30 days prior to inclusion in this study.
- Deemed unsuitable to participate in the study according to the judgment of the evaluator conducting the pre-selection.
- One SDU is defined as the average alcohol content of a standard drink in terms of alcohol strength and volume. One SDU is approximately 10 grams of alcohol, which equals:1 glass of wine (120 ml), 1 beer (330 ml), 1 small liquor (25 ml); 2 SDUs equal: 1 glass of cognac or liqueur (55 ml),1 whisky (70 ml),1 mixed drink (75 ml).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement: Double-blind, Randomized, Crossover Study
The objective of this study is to identify phenolic compound biomarkers of the intake of a mixture of Melissa officinalis extract, acerola extract and vitamin B5. This will be done through the study of their bioavailability and nutrikinetics by measuring their plasma concentrations and urinary excretion over 24h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects
- Conditions
- Nutrition, Healthy
- Being tested
- Placebo, M_ML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Intake of 400 mg placebo (maltodextrin; encapsulated) in the morning (09:00)
M_MLDietary supplement
Intake of 400 mg M_ML (encapsulated) in the morning (09:00)
M_MLDietary supplement
Intake of 400 mg M_ML (encapsulated) in the evening (19:00)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm receives 400 mg maltodextrin Receives: Dietary Supplement: Placebo |
| M_ML | Experimental | This arm receives 400 mg of M_ML. M_ML is a mixture of a polyphenol-rich Melissa officinalis extract, an acerola extract and vitamin B5. Receives: Dietary Supplement: M_ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma concentrations of phenolic metabolites after acute ingestion of the supplement/placebo
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using liquid chromatography-time of light-mass spectometry (LC-qToF-MS). Results will be reported in nanomolar (nM).
Measured: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Secondary outcomes (17)
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS.
Measured: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS.
Measured: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS.
Measured: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma half-life (T1/2) of phenolic metabolites after acute ingestion of the supplement/placebo
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS.
Measured: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of phenolic metabolites after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in serum cortisol after acute ingestion of the supplement/placebo
Serum samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using ECLIA (electrochemiluminescence immunoassay)
Measured: At baseline and at 30.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of melatonin after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 6-SMT (6-Sulfatoxymelatonin) after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3, 6, 10 and 24h after treatment intake.
Changes in 24h cumulative urinary excretion of AFMK (N1-acetyl-N2-formyl-5-methoxykynuramine) after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of AMK (N1-acetyl-5-methoxykynuramine) after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of cortisol after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of cortisone after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of tetrahydrocortisol after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of allo-tetrahydrocortisol after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 5-alfa-dihydrocortisol after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 11-oxo-cortisol after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 11-oxo-corticosterone after acute ingestion of the supplement/placebo
Urine samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using LC-qToF-MS, and transformed to total excretion through measured excreted urinary volume.
Measured: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start30 Apr 2025
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoni Caimari Palou, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949592
- Sponsor's protocol ID
- BIOLEMON
- Acronym
- BIOLEMON
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement: Double-blind, Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT06949592
- Acronym / sponsor ID
- BIOLEMON / BIOLEMON
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 29 Apr 2025 (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.
The objective of this study is to identify phenolic compound biomarkers of the intake of a mixture of Melissa officinalis extract, acerola extract and vitamin B5. This will be done through the study of their bioavailability and nutrikinetics by measuring their plasma concentrations and urinary excretion over 24h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm receives 400 mg maltodextrin |
| M_ML | Experimental | Dietary Supplement: M_MLThis arm receives 400 mg of M_ML. M_ML is a mixture of a polyphenol-rich Melissa officinalis extract, an acerola extract and vitamin B5. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 60 years old.
- Agree to follow the dietary and exercise guidelines of the study.
- Sign the informed consent form.
- Be able to read, write, and speak Spanish and/or Catalan.
Key exclusion criteria (20 listed)
- Body Mass Index (BMI) <18.5 kg/m² or ≥30 kg/m².
- Presence of intolerances or allergies related to polyphenols or any of the components of the products evaluated, such as acerola, maltodextrin, or Melissa officinalis.
- Use of medication that could affect the study results, including antibiotics, glucocorticoids, steroids, antidepressants (especially selective serotonin reuptake inhibitors (SSRIs), medications used to control sleep or stress, antipsychotics, anticonvulsants, oral contraceptives, beta-blockers, benzodiazepines, and antihypertensives.
- Regular consumption herbal or plant-based supplements. Participants who take multivitamin supplements may still participate in the study, provided they agree to stop taking them for 48 hours before and on the day of the intervention.
- Regular consumption of melatonin supplements. Participants who occasionally take melatonin may be included if they have had at least a one-week washout period since the last dose.
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 |
|---|---|---|
| PlaceboIntake of 400 mg placebo (maltodextrin; encapsulated) in the morning (09:00) | Dietary supplement | Placebo |
| M_MLIntake of 400 mg M_ML (encapsulated) in the morning (09:00) | Dietary supplement | M_ML |
| M_MLIntake of 400 mg M_ML (encapsulated) in the evening (19:00) | Dietary supplement | M_ML |
Primary outcome
Changes in plasma concentrations of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using liquid chromatography-time of light-mass spectometry (LC-qToF-MS). Results will be reported in nanomolar (nM).
17 secondary outcomes
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Change in plasma half-life (T1/2) of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of phenolic metabolites after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in serum cortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 30.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of melatonin after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 6-SMT (6-Sulfatoxymelatonin) after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3, 6, 10 and 24h after treatment intake.
Changes in 24h cumulative urinary excretion of AFMK (N1-acetyl-N2-formyl-5-methoxykynuramine) after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of AMK (N1-acetyl-5-methoxykynuramine) after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of cortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of cortisone after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of tetrahydrocortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of allo-tetrahydrocortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 5-alfa-dihydrocortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 11-oxo-cortisol after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
Changes in 24h cumulative urinary excretion of 11-oxo-corticosterone after acute ingestion of the supplement/placebo
Time frame: At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.
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 15 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Antoni Caimari Palou, PhD principal investigator
Fundació Eurecat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M_ML in people with Nutrition, Healthy, run by Fytexia at 1 site in Spain.
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 4 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 15 Jun 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Changes in plasma concentrations of phenolic metabolites after acute ingestion of the supplement/placebo (time frame: At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.