Pharmacokinetics Study of Antitumor B in Healthy Volunteers

Healthy Adults Clinical Trial

Official title: Pharmacokinetics Study of Antitumor B in Healthy Volunteers

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the single-dose oral pharmacokinetics of an herbal supplement - Antitumor B - in healthy subjects.

Clinical Trial Description

Antitumor B (ATB), also known as Zeng Sheng Ping, is a Chinese herbal mixture composed of six plants: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera. ATB is available as 300 mg tablets and has been traditionally used in China for dysplasia (dose 4-8 tables/ twice daily). Several studies in rodents and humans have been published demonstrating the chemopreventive activity of ATB against various cancers (e.g. lung, esophageal and oral). However, the investigators currently do not know what pharmacologically relevant concentration levels can be achieved systemically for different components of ATB in humans. Since it is a complex herbal mixture containing various key active components (KACs), relative levels of KACs in the ATB mixture can influence the bioavailability and pharmacokinetic of the individual KACs. The proposed study aim to estimate the plasma concentration of four key active components in a tablet with a chemical-defined ATB mixture. The investigators are interested in doing a human single-dose (8 tablets once) full pharmacokinetic study of ATB tablets. The investigators plan to collect 9 blood and 9 saliva samples from 8 healthy volunteers over a period of 24 hours (at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours) to

1. determine the saliva and plasma concentration of four key constituents of ATB (matrine, dictamnine, maackiain, fraxinellone) and

2. develop the in vivo correlation between plasma and saliva concentrations ;

Related Conditions & MeSH terms

• Healthy Adults

• NCT number: NCT04230057
• Study type: Observational
• Source: University of Houston
• Status: Active, not recruiting
• Start date: December 12, 2019
• Completion date: August 30, 2021