CsA 6 mg/kg Experiment CSV JSON

Natural product: Goldenseal (Hydrastis canadensis)
Associated study: The Effects of Berberine on the Pharmacokinetics of Ciclosporin A in Healthy Volunteers

In Vivo Interaction Study

CsA 6 mg/kg Experiment

No Effect (based on bioequivalence limits) was detected.

Object compound

cyclosporin a

Precipitant

berberine 19012197

Enzymes affected

CYP3A4 4306811

Transporters affected

P-gp (ABCB1)

Results

Converted Cmax, C12 and AUC from microgram/L to ng/mL (same decimal placement). C (plasma) taken at 12 hours.

Sample	Compound measured	Value	Measurement	Study sequence	Additional information	N replicates

Experimental Conditions

1 mL ulnar vein draws
Subjects not taking any medications

Study design

Parallel
Single dosing

Population

Demographic characteristics

Healthy volunteers
Males

Lifestyle factors

Nonsmokers

Number of subjects

Population additional information

Age (SD): 22.8 (2.2) years
Ht (SD): 173 (4.6) cm
Wt (SD): 64.3 (8.1) kg

Pharmacokinetic (PK) Sampling Information

Times of PK samples for object

0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours

Drug or Natural Product Administration

Object Administration — cyclosporin a

Administration route

Oral

Formulation

not specified

Total daily dose

6 mg/kg

Interval/frequency

Twice in total - one dose at day 0 and one dose at day 15

Duration

15 days

Precipitant Administration — berberine

Administration route

Oral

Formulation

not specified

Total daily dose

600 mg

Interval/frequency

300 mg BID

Duration

10 days (after 3-day washout of CsA first dose)

Natural Product Characteristics

Manufacturer/source

Shanghai Tianpin Pharmaceutic Factory, Chine

Year sourcing was completed

Not specified

Pharmacodynamics (PD) & Adverse Events

Pharmacodynamic measurement classes

Gastrointestinal disorders 35800000

Pharmacodynamic results

Stomach upset and diarrhea

Adverse event classes

Gastrointestinal disorders 35700000

NOTE