A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|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|
- The PK variables of the cocktail substrates with and without T89. [ Time Frame: 25 days (From Day 1 to Day 25) ]
caffine: AUC(0-12h)&Cmax; Omeprazole:AUC(0-12h)& Cmax; Midazolam:AUC(0-12h)& Cmax; Dextromethorphan:Dextromethorphan/Dextrorphan(12h Urine)
S-warfarin: AUC(0-96h)& Cmax;
- Safety assessments (AEs, Vital signs, ECG, Safety labs, INRs) [ Time Frame: subjects will be followed for the safety assessment from Day 0 to Day 35. ]
|Study Start Date:||January 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473888
|United States, Washington|
|Comprehensive Clinical Development NW Inc.|
|Tacoma, Washington, United States, 98418|
|Study Director:||Jason Zhixin GUO, M.D.||Tasly Pharmaceuticals Co. Ltd.|