A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes

Stable Angina Clinical Trial

Official title: An Open-label, One-sequence, Two Periods, Crossover Trial Study to Evaluate the Effect of T89 on the Pharmacokinetics of Five CYP450 Substrates Cocktail in Healthy Subjects

Status Completed

Clinical Trial Summary

Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study will help determine which types of drugs may interact with T89.

Clinical Trial Description

T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89 was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due to coronary heart disease, by the State Food and Drug Administration (SFDA) of China in 1993. There were more than 2 billion doses have been prescribed or used, in about 10,000,000 subjects, in short or long-term administration worldwide.

The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore, Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose response of T89 in patients with chronic stable angina pectoris in the United States.

T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN) as active constitutes, and using Borneol as transporting enhancer. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

• NCT number: NCT01473888
• Study type: Interventional
• Source: Tasly Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Completion date: January 2012