title: Absence of an effect of T89 on the steady-state pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers.
abstract: This open-label, multi-dose, single-center, sequential, inpatient study evaluated the effects of a two herb combination drug (T89, Danshen plus Sanqi) on the steady-state pharmacodynamics (PD) and pharmacokinetics (PK) of warfarin in 24 healthy volunteers. Twenty-three subjects attained a stable international normalized ratio (INR) by taking warfarin alone prior to 1-week of added-on use of T89. INR was not increased after the addition of T89 for 7 days (P > .05). The 90% confidence interval (CI) of the geometric mean ratio for maximum plasma concentrations (Cmax) and area under curve (AUClast ) of both R- and S-warfarin when warfarin was administered with or without T89 was within the 0.80 to 1.25 equivalence ratio. These results indicate that T89 has no effect on the steady-state PD and PK of warfarin. Warfarin and T89 dose adjustments are not required when these two drugs are co-administrated in clinical practice.
authors.affiliation: School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China; Tasly R&D Institute, Tasly Pharmaceutical Co., Ltd., Tianjin, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.forename: He
authors.initials: H
authors.lastname: Sun
authors.forename: Liu
authors.initials: L
authors.lastname: Yang
authors.forename: Ling-Yan
authors.initials: LY
authors.lastname: Li
authors.forename: Jing
authors.initials: J
authors.lastname: Hao
authors.forename: Dennis
authors.initials: D
authors.lastname: Ruff
authors.forename: Zhi-Xin
authors.initials: ZX
authors.lastname: Guo
mesh_terms: D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000097:blood / Q000493:pharmacokinetics*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D064368:Healthy Volunteers; D041743:Herb-Drug Interactions; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D053723:Panax notoginseng; D011517:Prothrombin Time; D027561:Salvia miltiorrhiza; D014859:Warfarin / Q000097:blood / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D004365:Drugs, Chinese Herbal; C581239:T89 herbal drug; D014859:Warfarin
keywords: T89; interaction; pharmacodynamics; pharmacokinetics; warfarin