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| Name | Class |
|---|---|
| Monitor CRO | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule | Drug | Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-72 hours |
| Cmax | Maximum observed plasma concentration for each analyte | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach maximum plasma concentration for each analyte | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) | Kayseri | Turkey (Türkiye) |
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| 0-72 hours |
| T1/2 | Half-life for each analyte | 0-72 hours |
| Lambda-z | Elimination rate constant for each analyte | 0-72 hours |