Overview

Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day

Status:
Completed
Trial end date:
2018-05-17
Target enrollment:
Participant gender:
Summary
Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the reference medicinal product Flector®, applied once and twice a day. Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy volunteers in comparison to the reference medicinal product Flector®, applied once and twice a day.
Phase:
Phase 1
Details
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Treatments:
Diclofenac
Diclofenac hydroxyethylpyrrolidine