CYP3A4 Experiment CSV JSON

In Vivo Interaction Study

CYP3A4 Experiment

Increased systemic exposure was detected.

midazolam 708298

  • CYP3A4 4306811

Results

Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Probe cocktail study
Fixed-sequence
Multiple dosing

Population

Females
Healthy volunteers
Males

Nonsmokers

CYP2D6 ultra-rapid metabolizer

12

(6 females) (age, mean ± SD = 24 ± 3.0 years; weight, 69.3 ± 14.2 kg)
Did not use botanical dietary supplements or non-prescription/prescription medications aside from oral contraception in the female group, which they continued.
All females had a negative prenancy test at baseline

Pharmacokinetic (PK) Sampling Information

1 and 6 hours

Drug or Natural Product Administration

Object Administration — midazolam

Oral

not specified

8 mg

once

twice in 28 day trial

Precipitant Administration — goldenseal root extract

Oral

capsule

2700 mg

three times daily

28 days

Natural Product Characteristics

Wild Oats Markets, Inc. Boulder, CO.

3034215

not specified

Pharmacodynamics (PD) & Adverse Events

Gastrointestinal disorders 35700000
General disorders and administration site conditions 35800000

Headache (4 of 12 subjects) and nausea (3 of 12 subjects)