CsA 6 mg/kg Experiment CSV JSON

In Vivo Interaction Study

CsA 6 mg/kg Experiment

No Effect (based on bioequivalence limits) was detected.

cyclosporin a

berberine 19012197

  • CYP3A4 4306811
  • 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

Parallel
Single dosing

Population

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

Pharmacokinetic (PK) Sampling Information

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

Drug or Natural Product Administration

Object Administration — cyclosporin a

Oral

not specified

6 mg/kg

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

15 days

Precipitant Administration — berberine

Oral

not specified

600 mg

300 mg BID

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

Natural Product Characteristics

Shanghai Tianpin Pharmaceutic Factory, Chine

Not specified

Pharmacodynamics (PD) & Adverse Events

Gastrointestinal disorders 35800000

Stomach upset and diarrhea

Gastrointestinal disorders 35700000