- 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 3 mg/kg Experiement
Increased systemic exposure was detected.
berberine 19012197
- CYP3A4 4306811
- P-gp (ABCB1)
Results
Converted Cmax, Cplasma (C12) and AUC from microgram/L to ng/mL (same decimal placement)
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Parallel
Single dosing
Healthy volunteers
Males
Nonsmokers
6
Age (SD): 22.8 (2.2) years
Ht (SD): 173 (4.6) cm
Wt (SD): 64.3 (8.1) kg
0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours
Drug or Natural Product Administration
Oral
not specified
3 mg/kg
Twice in total - one dose at day 0 and one dose at day 15
15 days
Oral
not specified
600 mg
BID
10 days (after 3 day washout of CsA first dose)
Shanghai Tianpin Pharmaceutic Factory, Chine
not specified
Pharmacodynamics (PD) & Adverse Events
Gastrointestinal disorders
35800000
Stomach upset and diarrhea
Gastrointestinal disorders
35700000