Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-01-01 @ 9:16 PM
Study NCT ID:
NCT06823895
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
Exploring the Pharmacokinetics of Oligonucleotides in Maixuekang Capsules in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: