- Natural product: Green tea (Camellia sinensis)
- Associated study: Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and polyphenon E.
In Vivo Pharmacokinetics Study
In vivo PK of tea polyphenols 400 mg Polyphenon E capsules
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Randomized crossover
Multiple dosing
Healthy volunteers
20
5 subjects per dose level, biased toward females at every dose level
0.5, 1, 2, 4, 6, 8, and 24 h after drug administration
Drug or Natural Product Administration
Oral
capsule
400
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
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