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The objective of this clinical trial is to learn the sequence and expression level of Maixuekang oligonucleotides in the plasma of healthy volunteers.
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.
This study is an exploratory study of the active substances in the marketed drug "Maixuekang Capsule". "Maixuekang Capsule" is a traditional Chinese patent medicines and simple preparations approved by the State Food and Drug Administration of China, which has been used for more than 20 years. It is made of live leeches through freeze-dried, containing protein and nucleotide of animal tissues.
In this study, the investigators will explore the sequence and expression levels of oligonucleotides in the plasma of healthy subjects in Maixuekang capsules at different time points before and after single and multiple administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-dose | Experimental | Maixuekang capsules, once, 1g, orally |
|
| multiple-dose | Experimental | Maixuekang capsules,1g each time, 3 times/day, 3 days, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maixuekang capsule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perform UMI Small RNA sequencing on blood samples at different time points | "Maixuekang Capsule" is a traditional Chinese patent medicines and simple preparations approved by the State Drug Administration of China, which has been used for more than 20 years. It is made of leeches through freeze drying. This project will collect blood samples before administration, as well as at 3, 3.5, 4, 6, 8, and 12 hours after administration. Unique Molecular Identifier small RNA Seq sequencing technology will be used to detect the small RNA sequences of the blood samples and compare them with the leech genome to identify which leech specific small RNA sequences have entered human blood, as well as the table of these sequences at different time points after administration | Single dose group: within 1 hour before administration, 3 hours, 3.5 hours, 4 hours, 6 hours, 8 hours, and 12 hours after administration; Multiple dose group: within 1 hour before the first administration, 10 hours, 16 hours, 28 hours, 40 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Number of participants with With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, with abnormal vital signs, abnormal physical examination, abnormal 12 lead electrocardiogram, and abnormal laboratory tests results | Single dose group: within 24 hours of administration; Multi dose group: within 5 days after the first administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan | Contact | +8613078891070 | huiyun1227@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | China |
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