Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Status Active, not recruiting

Clinical Trial Summary

A single dose of the study drug will be administered to healthy female subjects in a single period to obtain pharmacokinetic parameters for each active ingredient.

Clinical Trial Description

The study drug, EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine. It is manufactured by Exeltis İlaç San. ve Tic. A.Ş., Turkey. It is an antibacterial and antifungal medication that will be used in the treatment of common vaginitis (e.g. bacterial vaginosis, candidal vulvovaginitis). Its efficacy and safety were previously evaluated in a Phase III clinical trial. In this single-center, single-arm, single-dose, bioavailability study, pharmacokinetic parameters for each active ingredient will be evaluated in 18 healthy female subjects following intravaginal administration of this fixed-dose combination. ;

Study Design

Related Conditions & MeSH terms

Bioavailability

Clinical Trial Details

NCT number	NCT05361369
Study type	Interventional
Source	Exeltis Turkey
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	May 9, 2022
Completion date	September 2022

View Details

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