NCT06823895

Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules

Exploring the Pharmacokinetics of Oligonucleotides in Maixuekang Capsules in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Maixuekang capsule	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.

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: China