CYP3A4 Experiment CSV JSON

Natural product: Goldenseal (Hydrastis canadensis)
Associated study: In vivo effects of goldenseal, kava kava, black cohosh, and valerian on human cytochrome P450 1A2, 2D6, 2E1, and 3A4 phenotypes

In Vivo Interaction Study

CYP3A4 Experiment

Increased systemic exposure was detected.

Object compound

midazolam 708298

Precipitant

goldenseal root extract

Enzymes affected

CYP3A4 4306811

Results

Sample	Compound measured	Value	Measurement	Study sequence	Additional information	N replicates

Experimental Conditions

Study design

Probe cocktail study
Fixed-sequence
Multiple dosing

Population

Demographic characteristics

Females
Healthy volunteers
Males

Lifestyle factors

Nonsmokers

Phenotype

CYP2D6 ultra-rapid metabolizer

Number of subjects

Population additional information

(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

Times of PK samples for object

1 and 6 hours

Drug or Natural Product Administration

Object Administration — midazolam

Administration route

Oral

Formulation

not specified

Total daily dose

8 mg

Interval/frequency

once

Duration

twice in 28 day trial

Precipitant Administration — goldenseal root extract

Administration route

Oral

Formulation

capsule

Total daily dose

2700 mg

Interval/frequency

three times daily

Duration

28 days

Natural Product Characteristics

Manufacturer/source

Wild Oats Markets, Inc. Boulder, CO.

Year sourcing was completed

not specified

Pharmacodynamics (PD) & Adverse Events

Adverse event classes

Gastrointestinal disorders 35700000
General disorders and administration site conditions 35800000

Safety results

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

NOTE