In vivo PK of tea polyphenols 200 mg EGCG capsules CSV JSON

In Vivo Pharmacokinetics Study

In vivo PK of tea polyphenols 200 mg EGCG capsules

Results

The authors report a CL/F value but they don't have or mention administration of any IV formulation to use for calculating oral bioavailability (assuming F = (AUC_{po}XDose_{iv})/(AUC_{iv}XDose_{po}). So, I think that the they are really just reporting Cl from Dose/AUC. A similar comment applies to volume of distribution. These two values have not been entered into the repository.

Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Randomized crossover
Multiple dosing

Population

Healthy volunteers

5

Pharmacokinetic (PK) Sampling Information

Blood samples were collected before administration of the medication administration and 0.5, 1, 2, 4, 6, 8, and 24 h after drug administration. Study subjects self-collected urine before dosing and at three intervals during the 24 h period after dosing (0-4, 4-8, and 8-24 h)

Drug or Natural Product Administration

Natural Product Administration

Oral

capsule

200 mg

Fed

All study participants were required to refrain from the ingestion of tea or tea products for 7 days before the dose administration. The day before the pharmacokinetic study, study partici- pants were instructed to fast after midnight except for drinking water. On the pharmacokinetic study day, study subjects skipped breakfast and took no over the counter medications, vitamins, or health food products. Study participants came to the clinic in the early morning (6 – 8 a.m.) and were provided with one to two bagels for breakfast.

single dose

Natural Product Characteristics

Food Research Laboratories, Mitsui Norin Co., Ltd., (Fujieda City, Japan)

Each EGCG capsule contained 200 mg EGCG

not available

Pharmacodynamics (PD) & Adverse Events

General disorders and administration site conditions 35800000

Mild headache and fatigue