Pentoxifylline PKB171 Gel in Healthy Females Volunteers

Summary

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to evaluate the Safety and Tolerability of Pentoxifylline PKB171 Gel in Single-Dose Intravaginal Administration, followed by an Extension Study with Multiple-Dose Administration in Healthy Volunteers. The primary ojective was to determine the maximum tolerated dose (MTD) in terms of local tolerability of PKB171 after single-dose intravaginal administration in healthy female volunteers; the secondary objectives evaluated the safety and tolerability of PKB171 after single-dose intravaginal administration and the pharmacokinetic (PK) profile of PKB171 after single-dose intravaginal administration. The extension substudy evaluated the safety and tolerability of PKB171 after multiple-dose intravaginal administration at the MTD in healthy volunteers.

Timeline

Start

2016-01-27

Primary completion

2016-04-26

Completion

2016-09-21

Drugs

Indications

No indication recorded.