Indinavir/ Goldenseal Root Experiment CSV JSON

In Vivo Interaction Study

Indinavir/ Goldenseal Root Experiment

No Effect (based on bioequivalence limits) was detected.


  • CYP3A4 4306811


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


Healthy volunteers



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.

Pharmacokinetic (PK) Sampling Information

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

Object Administration — indinavir



800 mg


Two doses administered at beginning and end of two weeks

Precipitant Administration — goldenseal root extract



2280 mg

Two times daily without regard to meals; final dose taken 30 min prior to the administration of indinavir

Two weeks

Natural Product Characteristics

Nature’s Way, Springville, UT

not specified