NCT02720783

Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary

A Phase I Study of a Novel Antimycotic Vaginal Pessary Formulation (Econazole Nitrate 150 mg + Benzydamine HCl 6 mg) Administered Once Daily for 3 Days to Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.

Conditions

• Healthy Women

Interventions

Type	Name	Description
DRUG	Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary	Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary
DRUG	Placebo plus Econazole nitrate 150 mg vaginal pessary
DRUG	Placebo plus Benzydamine HCl 6 mg vaginal pessary
DRUG	Placebo vaginal pessary

Timeline

• Start date: 2016-03-04
• Primary completion: 2016-10-12
• Completion: 2016-10-12
• First posted: 2016-03-28
• Last updated: 2017-02-07

Locations

1 site across 1 country: Switzerland