Actively Recruiting
Exploring the Pharmacokinetics of Oligonucleotides in Maixuekang Capsules in Healthy Adults
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-02-12
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the sequence and levels of oligonucleotides in the blood plasma of healthy adults after taking Maixuekang capsules, a traditional Chinese medicine made from freeze-dried live leeches. This study aims to understand how these active substances behave in the body following single and multiple doses. The investigation focuses on healthy volunteers aged 18 to 45 years to gather detailed pharmacokinetic data. Participants are divided into two groups: one receives a single oral dose of 1 gram of Maixuekang capsules, while the other takes 1 gram orally three times a day for three days. The study examines oligonucleotide sequences and expression at various time points before and after dosing to compare the effects of single versus multiple administrations. During the trial, blood samples are collected at specified intervals to perform small RNA sequencing and monitor oligonucleotide levels. Safety is assessed by tracking adverse events within 24 hours after a single dose and up to five days after multiple doses. Participants must adhere to study requirements, including contraceptive use and dietary restrictions, throughout the trial, which is sponsored by Nanfang Hospital, Southern Medical University.
CONDITIONS
Brief 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 boundary ages)
- Male weight at least 50.0 kg, female weight at least 45.0 kg
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values)
- Normal or clinically insignificant abnormal medical history, vital signs, physical exam, lab tests, and ECG
- Ability and willingness to use effective contraception during the trial and for 6 months after
- Fully understand the study and voluntarily sign informed consent
You will not qualify if you...
- History or conditions causing thrombocytopenia, coagulation problems, or bleeding tendencies
- Allergy to heterologous animal proteins or leeches
- Smoking habit exceeding 5 cigarettes/day within the past 3 months or inability to stop during the trial
- Alcohol addiction or excessive consumption within the past 3 months or inability to abstain during the trial
- Recent excessive intake of caffeine or related substances before dosing
- Participation in drug or device trials within 3 months prior to screening
- Diseases or surgeries affecting drug absorption or metabolism within 6 months prior or planned during study
- History or positive test for drug abuse within specified timeframes
- Positive tests for hepatitis B, syphilis, HIV, or hepatitis C
- Pregnancy, lactation, or positive pregnancy test
- Acute illness or medication use during screening or study
- Difficulty with venous blood collection or history of fainting during blood draws
- Inability to follow a uniform diet
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days depending on dosing group
Participants receive Maixuekang capsules either as a single 1g oral dose or multiple 1g doses three times daily for 3 days. Blood samples are collected at specified time points before and after dosing to analyze oligonucleotide levels.
Multiple blood sample collections within 12 hours after single dose or up to 40 hours after multiple doses
Duration - Up to 5 days
Participants are monitored for adverse events within 24 hours after single dose or up to 5 days after the first multiple dose administration.
1 to 2 visits depending on dosing group
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, China
Actively Recruiting
Research Team
P
Pan
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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