Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how a medication called Maixuekang, in capsule form, behaves in the body of healthy volunteers. Specifically, the researchers want to see how the oligonucleotides (small pieces of genetic material) from Maixuekang are present in the blood after taking the capsules, both after a single dose and after taking them multiple times over three days. The goal is to better understand how these components are absorbed and expressed in the bloodstream.

To participate in this trial, volunteers must be healthy adults between the ages of 18 and 45, meet certain weight and body mass index (BMI) criteria, and not have any significant medical issues. Participants can expect to take either one capsule of Maixuekang or three capsules daily for three days. They will receive close monitoring throughout the study to ensure their safety and gather data on how the drug works in their body. It's important for potential participants to understand the study's procedures and possible side effects before agreeing to join.

Gender

ALL

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.