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Pharmacokinetic Study of Resveratrol Solid Beverage in Human Subjects

Pharmacokinetic Study of Resveratrol Solid Beverage in Human Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095657
Enrollment
Unknown
Registered
2025-01-10
Start date
2024-09-19
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

T1T2 group:Take test preparation T1 in the first cycle and test preparation T2 in the second cycle
T2T1 group:Take test preparation T2 in the first cycle and test preparation T1 in the second cycle

Sponsors

Wuhan Zijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18-40 years old (including 18 and 40 years old); 2) Gender: The proportion of males and females is appropriate; 3) Weight: Male >= 50.0kg, female >= 45.0kg, body mass index [BMI=weight (kg)/height^2 (m^2)] between 19.0-26.0kg/m^2 (including boundary values); 4) 90mmHg <= systolic blood pressure (sitting)<139mmHg, 60mmHg <= diastolic blood pressure (sitting)<89mmHg, 60 beats/min <= pulse <= 100 beats/min, 36.0 ? <= body temperature and frontal temperature) <= 37.0 ?. The specific situation will be determined by the researcher comprehensively; 5) Prior to the trial, I had a detailed understanding of the nature, significance, potential benefits, inconvenience, and potential risks of the trial, and voluntarily participated in the clinical trial. I was able to communicate well with the researchers, comply with the requirements of the entire study, and signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Individuals who have participated in clinical trials of other drugs/devices within the past 3 months and have used the investigational drugs/devices; 2. Patients with abnormal clinical manifestations that need to be excluded, including but not limited to neurological, cardiovascular, blood and lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and skeletal system diseases, especially those with any diseases that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage; 3. Individuals with a history of vomiting, diarrhea, or any physiological condition that can interfere with the test results within 7 days prior to the experiment; 4. Individuals with a specific history of allergies (asthma, urticaria, eczema, etc.), or those who are allergic to any medication, food, or pollen, or those with a known history of allergies to resveratrol; 5. Individuals who have lost blood or donated more than 400mL of blood within 3 months prior to the trial, or intend to donate blood during the trial period; 6. Pregnant or lactating women, or subjects (including male subjects) who have a fertility plan or a plan to donate sperm or eggs within two weeks before the last administration to three months after the last administration, and are unwilling or have not taken effective contraceptive measures; 7. Female subjects who have used oral contraceptives within 30 days prior to the trial, or who have used long-acting estrogen/progesterone injections or implants within 6 months prior to the trial; 8. General physical examination and laboratory tests (blood routine, blood biochemistry, urine routine, pregnancy test (only for females) within 7 days before the experiment, and electrocardiogram results within 14 days before the experiment judged by clinical doctors as abnormal and clinically significant; 9. Patients with one or more clinically significant tests for hepatitis B, hepatitis C, HIV, syphilis, etc; 10. Those who have undergone surgery within the 3 months prior to the experiment, or plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion; 11. Those who drink more than 14 units (1 unit=17.7 mL ethanol, that is, 1 unit=354 mL beer with 5% alcohol, 44 mL Baijiu with 40% alcohol, or 147 mL wine with 12% alcohol) per week within 3 months before the test, or who cannot abstain from drinking during the test; 12. Those who smoke an average of more than 5 cigarettes per day within the 3 months prior to the trial, or those who cannot stop using any tobacco or nicotine products (such as nicotine containing patches, chewing gum, etc.) during the trial period; 13. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) daily within the 3 months prior to the experiment; 14. Those who consume any food or beverage rich in caffeine/xanthine/determined by the researcher to affect drug absorption, distribution, metabolism, excretion (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) from self screening to -2 days of hospitalization, or those who cannot stop consuming the above food or beverage during the trial period; 15. Those who consume any foods rich in resveratrol, such as red wine, grapes,

Design outcomes

Primary

MeasureTime frame
Cmax;AUC0-t;AUC0-8;

Secondary

MeasureTime frame
Tmax;t1/2z;?z;AUC_%Extrap;AUC0-8;

Countries

China

Contacts

Public ContactZhou Songbo

Wuhan Zijing Hospital

3380838183@qq.com+86 183 2788 6149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026