Actively Recruiting
Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-02-12
12
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to learn the sequence and expression level of Maixuekang oligonucleotides in the plasma of healthy volunteers. 1. Detecting the sequence and expression levels of oligonucleotides in the blood of healthy subjects before and after a single administration of Maixuekang at different time points. 2. Detecting the sequence and expression levels of oligonucleotides in the blood of healthy subjects before and after multiple administrations of Maixuekang at different time points. Single dose group: Participants will be given Maixuekang capsules once, 1g, orally. Multiple dose group: Participants will receive 1g of Maixuekang capsules orally for 3 days, 3 times a day.
CONDITIONS
Official Title
Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female healthy subjects aged 18 to 45 years (including the critical value)
- Male weight 250.0kg, female weight 245.0kg
- Body mass index (BMI) ranges from 19.0 to 26.0 kg/m2 (including boundary values)
- Normal or clinically insignificant medical history, vital signs, physical examination, and clinical laboratory tests
- Subjects and their partners able to use effective contraceptive methods during the trial and for 6 months after
- Subjects understand the study and voluntarily sign informed consent
You will not qualify if you...
- History or causes of thrombocytopenia, coagulation dysfunction, or bleeding tendency
- Allergy to heterologous animal proteins or leeches
- Smoking habit in the past 3 months (more than 5 cigarettes per day) or inability to stop tobacco use during the trial
- Alcohol addiction or excessive drinking in the past 3 months or inability to avoid alcohol during the trial
- Excessive consumption of caffeine or caffeine-containing foods and beverages in the past 3 months or within 48 hours before dosing
- Participation in drug or medical device trials within 3 months before screening
- Difficulty swallowing or diseases/surgeries affecting drug absorption or metabolism within 6 months prior
- History or positive test for drug abuse within 5 years or recent drug use
- Positive tests for hepatitis B, syphilis, HIV, or hepatitis C
- Pregnant or lactating women or positive pregnancy test
- Acute illness or medication use from screening to dosing
- Difficulty or intolerance to venous blood collection
- Inability to follow a standardized diet
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, China
Actively Recruiting
Research Team
P
Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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