Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Anogenital Warts
Interventions
DRUG

Veregen

Patients in treatment arm 1 will apply Veregen® 15% ointment (approved commercial source in US) in a total of 750 mg/day for one week, corresponding to application of maximal about 106,9 mg catechins/d, thereof maximal 81 mg ECGg per day). Patients will be instructed to apply fix portions of 250 mg three times daily on the defined anogenital administration area.

OTHER

Green Tea

"Healthy volunteers in treatment arm 2 will drink Lipton® Green Limone in a total of 1500 mL/d for one week, in portions of 500 mL three times daily after the meals"

Trial Locations (1)

99084

CardioSec Clinical Reasearch GmbH, Erfurt

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediGene

INDUSTRY

NCT01490008 - Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers | Biotech Hunter | Biotech Hunter