drugset / Trial / NCT02713893

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream

NCT02713893

Phase 1 Completed 48 enrolled Angelini Pharma Cross Research S.A. · collab
RandomizedParallel-groupTriple-blindOther

Summary

The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.

Timeline

Start
2015-09
Primary completion
2016-06
Completion
2016-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzydamine Unknown 0.12 % Other
Subject Econazole Unknown 1 % Other

Indications

No indication recorded.