- Natural product: Goldenseal (Hydrastis canadensis)
- Associated study: Influence of Goldenseal Root on the Pharmacokinetics of Indinavir
In Vivo Interaction Study
Indinavir/ Goldenseal Root Experiment
No Effect (based on bioequivalence limits) was detected.
- CYP3A4 4306811
Results
Table 1
Converted Cmax from mg/L (in study) to ng/mL (shown above)
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Indinavir was administered on an empty stomach with 200 mL tap water following an overnight fast.
A standard lunch (ham or turkey sandwich, potato salad, coleslaw, soft drink) was served following the 4-hour blood sample.
Randomized crossover
Single dosing
Females
Healthy volunteers
Males
Nonsmokers
11
Eleven nonsmoking healthy subjects (6 males, 5 females) within 15% of ideal body weight and ranging in age from 21 to 47 years (mean 25.5 years) provided written informed consent and participated in the study. Subjects had no history of any chronic disease known to affect the metabolism and elimination of drugs. In addition, they did not take any prescription, over-the-counter, or herbal medicine known to influ- ence CYP3A4 activity for at least 1 month prior to the start of the study and were prohibited from taking these products throughout the study period. The study was approved by the Wayne State University Human Investigation Committee.
0, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours
Drug or Natural Product Administration
Oral
Capsule
800 mg
Once
Two doses administered at beginning and end of two weeks
Oral
Capsule
2280 mg
Two times daily without regard to meals; final dose taken 30 min prior to the administration of indinavir
Two weeks
Nature’s Way, Springville, UT
not specified