Part Used : ไม่ระบุ
Activity : EFFECTS ON PHARMACOKINETIC
Solvent/Active Compound : -
Type of experiment : human
Type of animal : -
Type of study : Open trial
N(Total) : 24 (M/F=23/1)
N(Treatment) : -
Sex : Both sex
Age : 23-48 years
Route : Oral administration
Dose/Conc.(herb) : 225 mg, two doses, one in the morning, one in the evening
Duration : 7 days
Type of interaction : P.Kinetics & P.Dynamics
Interaction with drug : Warfarin
Dose/Conc.(drug) : 2-6.5 mg (mean 4.3 mg)
Remark : T89 has no effect on the steady-state pharmacodynamics (PD) and pharmacokinetics (PK) of warfarin.
Note : Subject total: healthy volunteers. In the run-in period (Days 1 to 17), each subject took 5 mg of warfarin on Days 1 and 2. The warfarin dose from Days 3 to 12 was titrated up or down, based on the daily INR measurement to maintain an INR in the range of 1.3-1.9. Subjects were eligible to receive both warfarin and T89* starting on Day 18 if their INR was in the range of 1.3-1.9 and varied 0.2 over three consecutive days from Days 12 to 17. Subjects received maintenance warfarin dosing and T89 concomitantly during the treatment phase (Days 18 to 24).
*T89: consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and an absorption enhancer, borneol.
