Pharmacological ActionNCT06324370
Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)
A study testing Virgin Coconut Oil in people with Pharmacological Action, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
Trial summary
This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. 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
- Pharmacological Action
- What is being tested?
- Virgin Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePhilippines
- Study dates
- 13 Apr 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy Filipino male
- 18-45 years of age
- signed written informed consent obtained
- body-mass index of ≥18.5 kilogram per meter-squared (kg/m2) and ≤ 24.9 kg/m2, with body weight not less than 50 kilogram(kg)
Who cannot join
- history of allergy and/or sensitivity to virgin coconut oil, any of its constituents, or related drugs
- positive Coronavirus Disease (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test
- history of anaphylaxis or angioedema
- systolic Blood Pressure (BP) of less than 90 mm Hg and/or diastolic BP of less than 60 mm Hg
- pulse rate of less than 50 beats/minute
- body weight +/-15% optimum weight as related to height and body frame
Show all 18Show fewer
- history of tuberculosis or use of anti-tuberculosis drugs within 6 months prior to entry into study clinically significant gastrointestinal, cardiovascular, renal, hepatic, endocrine, metabolic, neurologic, psychiatric, hematological or other abnormalities, as judged by the Investigator
- history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes
- gastrointestinal disorders which may impair drug absorption, or other conditions which could modify the absorption of the study drug, as judged by the Investigator clinically significant deviation in the clinical chemistries (liver and renal function tests) and hematology at visit 1 which may impair assessment, as judged by the Investigator
- positive pre-study urine drug screen
- positive/reactive Hepatitis B and human immunodeficiency virus (HIV)
- use of any prescription drug within 30 days or any over-the-counter (OTC) drug within 14 days prior to and during the study inaccessibility of veins in left and right arm donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
- subjects who cannot abstain from grapefruit, citrus fruits and food and/or beverages that contain caffeine or other xanthines
- an unusual diet, for whatever reason, e.g., low sodium diet, for two weeks prior to receiving any medication and throughout subject's participation in the study current smoker or smoking within two months prior to study enrollment
- consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, and one measure/one ounce of spirit)
- participation in a clinical study within 3 months prior to visit 1
- significant illness during the 4 weeks preceding screening of the study
- having an occupation or requirement of driving a vehicle or operate a complex machinery before 21 days of taking the drug in both periods
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
City of Taguig, National Capital Region, 1630
About this study
Official title: Bioequivalence of Virgin Coconut Oil (VCO) Among Healthy Filipino Male Adults: An Exploratory Pharmacokinetic Study
This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).
Read the detailed description
Virgin coconut oil (VCO) will be administered with 240 ml water and standardized food on dosing periods, with a 5-day interval between the single-dose (0.6 ml/kg body weight) and the multiple-dose (1.2 ml/kg body weight divided into three doses daily) study periods. For the single-dose study, blood for PK analysis will be collected at pre-dose (-0.5 and 0 hours), then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. For the multiple-dose study, blood samples will be collected on the last day of dosing before the 2nd dose (at -0.5 and 0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. Sample collection will be continued after the last multiple dose at the following time points: 48, 72, 96, 120 and 144 hours. In addition, pre-dose blood samples will be collected daily from Day 8-12 to determine trough plasma concentrations and the approach to steady state. Blood samples will be sent to the Ateneo De Manila University (AdMU) for gas chromatography-mass spectrometry (GC-MS) analysis. Established primary and secondary endpoints for pharmacokinetics and safety and tolerability will be evaluated.
This study is necessary to establish human data on the pharmacokinetics of virgin coconut oil (VCO).
- Conditions
- Pharmacological Action
- Being tested
- Virgin Coconut Oil
- Keywords
- Pharmacokinetic Study, Bioequivalence, Virgin Coconut Oil, Filipino, Philippines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virgin Coconut OilDietary supplement
Also called VCO
Virgin Coconut Oil (VCO) will be administered with 240 mL water and standardized food during dosing periods.While the participant is standing up, each dose will be administered orally with at least 240 mL of water and standardized meal after an overnight fast of at least 10 hours on each occasion. The time of dosing will be recorded to the nearest minute in the case report form (CRF).
No other liquid or solid food intake is permitted during this time. Fluid intake will be ad libitum 4 hours post-dose. There will be a washout interval of 7 days between the single- and multiple-dose studies.
Participants will not be permitted to take any prescribed medication or over-the-counter products (including vitamins and herbal supplements) within 14 days prior to dosing or during the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Filipino male participants (18 to 45 yrs old) | Experimental | Healthy Filipino male participants 18 to 45 years old with optimum weight as related to height and body frame.
1.2ml/kg/dose of virgin coconut oil (VCO) will be administered orally with 240 ml of water and standardized food for a single dose, and 0.6ml/kg/dose of virgin coconut oil (VCO) with 240 ml of water and standardized food twice a day for 7 days for multiple doses. Receives: Dietary Supplement: Virgin Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC0-t)
Area under the concentration-time curve from administration to the last observed concentration at time t hr
Measured: 25 days
Pharmacokinetics (Cmax)
Maximum plasma concentration
Measured: 25 days
Secondary outcomes (24)
Pharmacokinetics (AUC0-inf)
Area under the concentration-time curve from time zero to infinity
Measured: 25 days
Pharmacokinetics (tmax)
Time to Cmax
Measured: 25 days
Pharmacokinetics (Kel)
Terminal elimination rate constant
Measured: 25 days
Pharmacokinetics (t1/2)
Terminal half-life
Measured: 25 days
Vital Signs (Systolic and Diastolic Blood Pressure)
This measures the force of blood against artery walls and can indicate cardiovascular health, risk of stroke, and other conditions like hypertension or hypotension.
Measured: 25 days
Vital Signs (Pulse rate)
This measures the heart rate and rhythm, indicating the heart's health and overall circulatory system efficiency. An irregular or abnormal pulse can indicate cardiac issues or other systemic health problems.
Measured: 25 days
Vital Signs (Body temperature)
Body temperature is a crucial indicator of metabolic and thermoregulatory function. Abnormal temperatures can indicate infections, inflammations, hormonal imbalances, or reactions to medication.
Measured: 25 days
Vital Signs (Respiratory rate)
Observing the rate, depth, and pattern of breaths, respiration rate can reveal issues related to lung function and oxygenation and can even signal distress or anxiety.
Measured: 25 days
Safety and Tolerability (Adverse events)
Adverse events
Measured: 25 days
Post Study Evaluation (Fasting Blood Sugar Test)
Fasting Blood Sugar Test is a blood test that measures the blood sugar level in the body after at least 8 hours of fasting without food or water.
Measured: 25 days
Post Study Evaluation (Blood Urea Nitrogen Test)
The blood urea nitrogen test also called the BUN test measures the urea nitrogen in the blood. It is recommended to diagnose kidney diseases.
Measured: 25 days
Post Study Evaluation (Creatinine)
A Creatinine test checks the level of this chemical in either the blood or urine. Creatinine levels can provide an indicator of how well the kidneys are working.
Measured: 25 days
Post Study Evaluation (Uric Acid)
Uric Acid test measures the levels of Uric Acid in the blood. Uric Acid is a nitrogenous compound that is formed as a by-product of metabolic activities and has been eliminated by the kidneys. This test is done to analyse gout and to measure the efficacy of medication that lowers Uric Acid.
Measured: 25 days
Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test)
The Serum Glutamic Pyruvic Transaminase (SGPT) or Alanine Aminotransferase Test (ALT) assesses liver health, detecting liver damage, hepatitis, or monitoring conditions affecting the liver.
Measured: 25 days
Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test)
A serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST) test measures the levels of the enzyme AST in the blood to assess liver health. It is recommended in case of symptoms of the liver disorder, such as pain in the abdomen, nausea, vomiting, and yellow skin (jaundice).
Measured: 25 days
Post Study Evaluation (Alkaline Phosphatase Test)
The Alkaline Phosphatase (ALP) test measures the Alkaline Phosphatase levels in the blood. Alkaline Phosphatase (ALP) is an enzyme that is found in various tissues throughout the body. The maximum concentrations of ALP are present in the cells of the bone and liver. Usually, raised levels of ALP are caused by liver disease or bone disorders.
Measured: 25 days
Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test)
A total protein and A/G ratio test is often included as part of a comprehensive metabolic panel, a test that measures proteins and other substances in the blood. It may also be used to help diagnose kidney disease, liver disease, or nutritional problems.
Measured: 25 days
Post Study Evaluation (Indirect, Direct and Total Bilirubin)
Bilirubin test measures the levels of bilirubin in the blood. Higher than usual levels of bilirubin may indicate different types of liver or bile duct problems. Sometimes, higher bilirubin levels may be caused by an increased rate of destruction of red blood cells.
Measured: 25 days
Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides)
A complete cholesterol test - also called a lipid panel or lipid profile - is a blood test that can measure the amount of cholesterol and triglycerides in the blood. A cholesterol test can help determine the risk of the buildup of fatty deposits (plaques) in the arteries that can lead to narrowed or blocked arteries throughout the body (atherosclerosis). Results that fall outside the reference range, especially those above the upper normal level, may indicate the presence of disease or a need for further testing.
Measured: 25 days
Post Study Evaluation (Lipase Test)
This test measures the amount of lipase in the blood. Lipase is an enzyme that is made by the pancreas. It helps the body digest fats. Higher levels of lipase may mean that one has a problem with the pancreas. Most often this means acute pancreatitis, or sudden inflammation of the pancreas.
Measured: 25 days
Post Study Evaluation (Amylase Test)
Tests for amylase in blood or urine are mainly used to diagnose problems with the pancreas, including pancreatitis, which is an inflammation of the pancreas. It is also used to monitor chronic (long-term) pancreatitis.
Measured: 25 days
Post Study Evaluation (Complete Blood Count with Platelet Count Test)
A complete blood count is a common blood test that is often part of a routine checkup. Complete blood counts can help detect a variety of disorders including infections, anemia, diseases of the immune system, and blood cancers.
Measured: 25 days
Post Study Evaluation (Complete Urinalysis)
A urinalysis is a common test that can assess many different aspects of one's health with a urine sample. Healthcare providers often use urinalysis tests to screen for or monitor certain health conditions and to diagnose urinary tract infections.
Measured: 25 days
Post Study Evaluation (Fecalysis)
A fecalysis is a series of tests done on a stool (feces) sample to help diagnose certain conditions affecting the digestive tract.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start13 Apr 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Nutrition Research Institute, Philippines
- Sponsor type
- Other government
- Collaborators
- Ateneo de Manila University, De La Salle Medical and Health Sciences Institute
- Responsible party
- Principal investigator, Carl Vincent D. Cabanilla, Food and Nutrition Research Institute, Philippines
- Investigators
- Carl Vincent D. Cabanilla, Bachelor's, Principal investigator, Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324370
- Sponsor's protocol ID
- FIERC-2022-023
- Status last verified
- May 2025
- First submitted
- 14 Dec 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Virgin Coconut Oil (VCO) Among Healthy Filipino Male Adults: An Exploratory Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT06324370
- Acronym / sponsor ID
- FIERC-2022-023
- Conditions
- Pharmacological Action
- Keywords
- Pharmacokinetic Study, Bioequivalence, Virgin Coconut Oil, Filipino, Philippines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Food and Nutrition Research Institute, PhilippinesOther government
- Collaborators
- Ateneo de Manila University, De La Salle Medical and Health Sciences Institute
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (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 is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).
Detailed description
Virgin coconut oil (VCO) will be administered with 240 ml water and standardized food on dosing periods, with a 5-day interval between the single-dose (0.6 ml/kg body weight) and the multiple-dose (1.2 ml/kg body weight divided into three doses daily) study periods. For the single-dose study, blood for PK analysis will be collected at pre-dose (-0.5 and 0 hours), then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. For the multiple-dose study, blood samples will be collected on the last day of dosing before the 2nd dose (at -0.5 and 0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. Sample collection will be continued after the last multiple dose at the following time points: 48, 72, 96, 120 and 144 hours. In addition, pre-dose blood samples will be collected daily from Day 8-12 to determine trough plasma concentrations and the approach to steady state. Blood samples will be sent to the Ateneo De Manila University (AdMU) for gas chromatography-mass spectrometry (GC-MS) analysis. Established primary and secondary endpoints for pharmacokinetics and safety and tolerability will be evaluated.
This study is necessary to establish human data on the pharmacokinetics of virgin coconut oil (VCO).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions.
| Arm | Type | Receives |
|---|---|---|
| Healthy Filipino male participants (18 to 45 yrs old) | Experimental | Dietary Supplement: Virgin Coconut OilHealthy Filipino male participants 18 to 45 years old with optimum weight as related to height and body frame. 1.2ml/kg/dose of virgin coconut oil (VCO) will be administered orally with 240 ml of water and standardized food for a single dose, and 0.6ml/kg/dose of virgin coconut oil (VCO) with 240 ml of water and standardized food twice a day for 7 days for multiple doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Filipino male
- 18-45 years of age
- signed written informed consent obtained
- body-mass index of ≥18.5 kilogram per meter-squared (kg/m2) and ≤ 24.9 kg/m2, with body weight not less than 50 kilogram(kg)
Key exclusion criteria (18 listed)
- history of allergy and/or sensitivity to virgin coconut oil, any of its constituents, or related drugs
- positive Coronavirus Disease (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test
- history of anaphylaxis or angioedema
- systolic Blood Pressure (BP) of less than 90 mm Hg and/or diastolic BP of less than 60 mm Hg
- pulse rate of less than 50 beats/minute
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 |
|---|---|---|
| Virgin Coconut OilAlso: VCOVirgin Coconut Oil (VCO) will be administered with 240 mL water and standardized food during dosing periods.While the participant is standing up, each dose will be administered orally with at least 240 mL of water and standardized meal after an overnight fast of at least 10 hours on each occasion. The time of dosing will be recorded to the nearest minute in the case report form (CRF). No other liquid or solid food intake is permitted during this time. Fluid intake will be ad libitum 4 hours post-dose. There will be a washout interval of 7 days between the single- and multiple-dose studies. Participants will not be permitted to take any prescribed medication or over-the-counter products (including vitamins and herbal supplements) within 14 days prior to dosing or during the course of the study. | Dietary supplement | Healthy Filipino male participants (18 to 45 yrs old) |
Primary outcome
Pharmacokinetics (AUC0-t)
Time frame: 25 days
Area under the concentration-time curve from administration to the last observed concentration at time t hr
Pharmacokinetics (Cmax)
Time frame: 25 days
Maximum plasma concentration
24 secondary outcomes
Pharmacokinetics (AUC0-inf)
Time frame: 25 days
Pharmacokinetics (tmax)
Time frame: 25 days
Pharmacokinetics (Kel)
Time frame: 25 days
Pharmacokinetics (t1/2)
Time frame: 25 days
Vital Signs (Systolic and Diastolic Blood Pressure)
Time frame: 25 days
Vital Signs (Pulse rate)
Time frame: 25 days
Vital Signs (Body temperature)
Time frame: 25 days
Vital Signs (Respiratory rate)
Time frame: 25 days
Safety and Tolerability (Adverse events)
Time frame: 25 days
Post Study Evaluation (Fasting Blood Sugar Test)
Time frame: 25 days
Post Study Evaluation (Blood Urea Nitrogen Test)
Time frame: 25 days
Post Study Evaluation (Creatinine)
Time frame: 25 days
Post Study Evaluation (Uric Acid)
Time frame: 25 days
Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test)
Time frame: 25 days
Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test)
Time frame: 25 days
Post Study Evaluation (Alkaline Phosphatase Test)
Time frame: 25 days
Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test)
Time frame: 25 days
Post Study Evaluation (Indirect, Direct and Total Bilirubin)
Time frame: 25 days
Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides)
Time frame: 25 days
Post Study Evaluation (Lipase Test)
Time frame: 25 days
Post Study Evaluation (Amylase Test)
Time frame: 25 days
Post Study Evaluation (Complete Blood Count with Platelet Count Test)
Time frame: 25 days
Post Study Evaluation (Complete Urinalysis)
Time frame: 25 days
Post Study Evaluation (Fecalysis)
Time frame: 25 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Carl Vincent D. Cabanilla, Bachelor's principal investigator
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virgin Coconut Oil in people with Pharmacological Action, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
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 18 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: under way, not looking for participants, as of the sponsor's last update on 11 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 Philippines. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pharmacokinetics (AUC0-t) (time frame: 25 days). The study lists 2 primary outcomes in all. 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 11 Jun 2025.