Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 45

Exploring the effects of Maixuekang capsules on healthy volunteers

Official title: Exploring the Pharmacokinetics of Oligonucleotides in Maixuekang Capsules in Healthy Subjects

Run by Nanfang Hospital, Southern Medical University · NCT06823895 · Data updated 2026-11-12

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

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Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment12 (estimated)
SponsorNanfang Hospital, Southern Medical University
Academic / other
Locations1 site (Guangzhou)
StatusRecruiting
StartedSeptember 25, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 12, 2025
Trial IDNCT06823895 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Nanfang Hospital, Southern Medical University
    Guangzhou, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.