A Phase 1 interventional study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule in Bioavailability, sponsored by Exeltis Turkey. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Exeltis Turkey · Phase 1, Interventional, and Other
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.
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.
Exeltis Turkey is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule will be administered once as a single dose during a single-period.
Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine
AUC0-72
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations for each analyte
Time frame: 0-72 hours
Cmax
Maximum observed plasma concentration for each analyte
Time frame: 0-72 hours
Tmax
Time to reach maximum plasma concentration for each analyte
Time frame: 0-72 hours
AUC0-inf
Area under the plasma concentration-time profile from time zero to infinity based on observed plasma concentrations for each analyte
Time frame: 0-72 hours
T1/2
Half-life for each analyte
Time frame: 0-72 hours
Lambda-z
Elimination rate constant for each analyte
Time frame: 0-72 hours
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Exeltis Turkey