CsA in Renal Transplant patients CSV JSON

Natural product: Goldenseal (Hydrastis canadensis)
Associated study: Effects of berberine on the blood concentration of cyclosporin A in renal transplanted recipients: clinical and pharmacokinetic study

In Vivo Interaction Study

CsA in Renal Transplant patients

Increased systemic exposure was detected.

Object compound

cyclosporin a

Precipitant

berberine 19012197

Results

Table 5

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

Sample	Compound measured	Value	Measurement	Study sequence	Additional information	N replicates

Experimental Conditions

Study design

Fixed-sequence
Parallel
Multiple dosing

Population

Demographic characteristics

Females
Males
Patients

Number of subjects

Population additional information

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

Times of PK samples for object

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

Drug or Natural Product Administration

Object Administration — cyclosporin a

Administration route

Oral

Formulation

capsule

Total daily dose

6 mg/kg

Interval/frequency

Twice Daily

Duration

13 days

Precipitant Administration — berberine

Administration route

Oral

Formulation

tablet

Total daily dose

600 mg

Interval/frequency

three times daily

Duration

13 days

Natural Product Characteristics

Year sourcing was completed

unspecified

Pharmacodynamics (PD) & Adverse Events

Adverse event classes

Gastrointestinal disorders 35700000

Safety results

Constipation (n=3)

NOTE