In vivo PK of tea polyphenols 200 mg Polyphenon E capsules CSV JSON

In Vivo Pharmacokinetics Study

In vivo PK of tea polyphenols 200 mg Polyphenon E capsules

Results

All of these results are the sum of unchanged and conjugated forms reported in Table 3

Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Randomized crossover
Multiple dosing

Population

Healthy volunteers

20

5 subjects per dose level, biased toward females at every dose level

Pharmacokinetic (PK) Sampling Information

0.5, 1, 2, 4, 6, 8, and 24 h after drug administration

Drug or Natural Product Administration

Natural Product Administration

Oral

capsule

200

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

1 day

Natural Product Characteristics

Food Research Laboratories, Mitsui Norin Co., Ltd., (Fujieda City, Japan) and Chemoprevention Agent Development Re- search Group, National Cancer Institute

2000

This experiment used capsules containing 200 mg of EGCG, 37 mg of EGC, and 31 mg of EC in the Polyphenon E formulation.

Source year is an assumption based on publication date

Pharmacodynamics (PD) & Adverse Events

General disorders and administration site conditions 35800000

Mild headache and fatigue