Pentoxifylline PKB171 Gel in Healthy Females Volunteers

"Subjects received a single dose of pentoxifylline PKB171 gel or placebo, in a one-dose form with an applicator device that allowed for vaginal administration following the randomisation list:~* First dose level: 2% (100 mg)~* Second dose level: 3% (150 mg)~* Third dose level: 4% (200 mg) The treatment was provided by a member of the investigator's staff and self-administered by volunteers under clinical supervision.~The dose-escalation process enabled to determine MTD or the highest dose that was safe to administer in later studies was determined. The results of this study helped to define the recommended doses to be used in the multiple-dose extension."

PKB vaginal gel at the MTD or placebo once every 24 hours for two consecutive days