Exploring the effects of Maixuekang capsules on healthy volunteers

Exploring the Pharmacokinetics of Oligonucleotides in Maixuekang Capsules in Healthy Subjects

This study is testing how Maixuekang capsules affect healthy volunteers by looking at how certain substances in their blood change after taking the capsules.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06823895 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate the sequence and expression levels of oligonucleotides in the plasma of healthy volunteers after administering Maixuekang capsules. Participants will be divided into two groups: one receiving a single dose and the other receiving multiple doses over three days. Blood samples will be collected at various time points to assess the pharmacokinetics of the oligonucleotides. The study focuses on understanding how these oligonucleotides behave in the body, which may provide insights into the drug's effects.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 45 who meet specific weight and BMI criteria.

Not a fit: Patients with a history of thrombocytopenia, coagulation dysfunction, or bleeding tendencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of Maixuekang's pharmacokinetics, potentially leading to improved therapeutic applications.

How similar studies have performed: While this study explores a traditional Chinese medicine, similar pharmacokinetic studies have shown promise in understanding drug behavior, though this specific approach may be novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female healthy subjects aged 18 to 45 years (including the critical value);
2. Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body mass index (BMI) ranges from 19.0 to 26.0 kg/m2 (including boundary values);
3. Normal or abnormal medical history, vital signs, physical examination, clinical laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function test), 12 lead electrocardiogram, etc. have no clinical significance;
4. The subjects and their partners were able to take effective contraceptive measures during the trial period and did not have any fertility plans during the trial period or within 6 months after the trial ended;
5. The subjects fully understand the content, process, and possible adverse reactions of the experiment and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Any previous cause or disease that leads to thrombocytopenia, coagulation dysfunction, or bleeding tendency, including recurrent gum bleeding, peptic ulcers, severe or long-term heavy menstrual flow, etc;
2. Those who are allergic to heterologous animal proteins and leeches;
3. Individuals who have a smoking habit within the previous 3 months (averaging over 5 cigarettes per day) or who cannot stop using any tobacco products throughout the entire trial period after being selected;
4. Screening for those who have been addicted to alcohol within the past 3 months (drinking more than 14 units of alcohol per week: 1 unit=285mL of beer, 25mL of spirits, or 100mL of wine) or have consumed any alcoholic products or alcohol breath tests positive within 24 hours before administration, or those who cannot accept the prohibition of drinking throughout the entire trial period after being selected;
5. Those who have consumed excessive amounts of tea, coffee, or beverages containing caffeine within the past 3 months, or have consumed any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) or xanthine (such as dragon fruit, mango, etc.) or citrus fruits of the Rutaceae family (such as grapefruit, etc.) within 48 hours before administration;
6. Those who have participated in drug trials and taken the investigational drug within 3 months prior to the screening period, or those who have participated in medical device research within 3 months of the screening period;
7. Patients who have difficulty swallowing or have any diseases (whether cured or not) or surgeries (excluding appendectomy) that affect drug absorption, distribution, metabolism, and excretion, as well as gastric motility and pH value, within the 6 months prior to screening, or who plan to undergo surgery during the study period;
8. Have a history of drug abuse or tested positive for drug abuse within the past 6 months prior to screening;
9. Individuals who have tested positive for drug screening or have a history of drug abuse within 5 years prior to their first use of the study drug, or have used drugs within 3 months prior to their first use of the study drug;
10. Individuals who are positive for hepatitis B surface antigen, Treponema pallidum antibody, human immunodeficiency virus antibody, and hepatitis C antibody;
11. Pregnant and lactating women or those whose blood β - HCG test is positive;
12. Acute illness or concomitant medication occurs from the screening stage to the study medication;
13. Difficulty in venous blood collection, or inability to tolerate venipuncture blood collection, or a history of dizziness or needle fainting;
14. Those who cannot follow a uniform diet (such as having special dietary requirements, intolerance to standard meal foods, etc.);
15. The researcher determines that the subjects have any other circumstances that make them unsuitable to participate in this clinical study.

Where this trial is running

Guangzhou

• Nanfang Hospital, Southern Medical University — Guangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Pan

Conditions: Healthy