CsA in Renal Transplant patients CSV JSON

In Vivo Interaction Study

CsA in Renal Transplant patients

Increased systemic exposure was detected.

cyclosporin a

berberine 19012197

Results

Table 5

Fluctuation Index: Control - 2.8 (0.6) Test 1.4 (0.7) p<0.01

Sample Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Fixed-sequence
Parallel
Multiple dosing

Population

Females
Males
Patients

6

Within 1 month after receiving the renal transplant operation, six recipients (three males and three females) were selected—44.0±4.5 years in age, 165.2±8.8 cm in height and 59.0±13.9 kg in weight. All had normal hepatic function. They had been treated orally with 3 mg/kg CsA (twice per day) for 12.7±5.9 days before the start of the trial.

Pharmacokinetic (PK) Sampling Information

0, 2, 4, 6, 8,10, 12 hours

Drug or Natural Product Administration

Object Administration — cyclosporin a

Oral

capsule

6 mg/kg

Twice Daily

13 days

Precipitant Administration — berberine

Oral

tablet

600 mg

three times daily

13 days

Natural Product Characteristics

unspecified

Pharmacodynamics (PD) & Adverse Events

Gastrointestinal disorders 35700000

Constipation (n=3)