PK and safety after multiple-dose administration of epigallocatechin gallate (EGCG) 800 mg CSV JSON

In Vivo Pharmacokinetics Study

PK and safety after multiple-dose administration of epigallocatechin gallate (EGCG) 800 mg

Results

Sample Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Multiple dosing

Population

Healthy volunteers

8 subjects with Fitzpatric skin type II or III

The subjects were in performance status 0–1 (determined by Southwest Oncology Group Performance Status Criteria) and have normal liver and renal function. Subjects were excluded if they were pregnant, had cancers of any type within the past 5 years, had severe metabolic disorders or other life-threatening acute or chronic diseases, had weight loss > 10%, or had gastric ulcer within the last 6 months.

Pharmacokinetic (PK) Sampling Information

On the first treatment day, a fasting blood sample was collected before ingestion of the study medication. Blood samples were collected at 0.5, 1, 2, 3.5, 5, 6.5, 8, and 24 h after drug administration on the first and last treatment day. For placebo group, only a fasting blood sample was collected on the last treatment day.

Incomplete sample collection occurred with one patient, therefore only data from 7 subjects were included in the analysis

Drug or Natural Product Administration

Natural Product Administration

Oral

capsule

800 mg epigallocatechin gallate (EGCG)

Fed

with a standard light breakfast

once daily

4 weeks

Natural Product Characteristics

Chemoprevention Agent Development Research Group, National Cancer Institute (Bethesda, MD)

On average, each EGCG capsule contained 200 mg EGCG and pharmaceutical excipients consisting of pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.

not available

On the basis of the content analysis performed every 6 months, green tea polyphenols were found to be stable at room temperature and protected from enviornmental extremes.

Pharmacodynamics (PD) & Adverse Events

Gastrointestinal disorders 35700000
Musculoskeletal and connective tissue disorders 36500000
Nervous system disorders 36700000

All of the reported events have been rated as mild events (grade 1). For most events, the incidence reported in the treatment groups was not significantly more than that in the placebo group. Mild nausea was more frequent after the 800-mg once daily treatment than that in the placebo group (5, 3, and 1 occurrence for 800 mg EGCG once daily, 800 mg EGCG as Polyphenon E once daily, and placebo, respectively). Complete blood count and a panel of blood chemistry profiles were obtained before and after 4 weeks of daily administration of the study agent. No significant changes were observed in these clinical laboratory measurements (data not shown).