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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single Center, Single Arm, Single Dose, Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule (a Fixed Dose Combination of 600 mg Fenticonazole Nitrate + 1000 mg Tinidazole + 100 mg Lidocaine) in 18 Healthy Female Subjects

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female adult subject with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year), Subject with a body weight ≥ 50 kg and body mass index between 16 and 30 kg/m2 Informed consent signed by the subject. Exclusion Criteria: Positive rapid antigen or polymerase chain reaction test result for COVID-19 Pregnancy and/or breastfeeding, or subject who doesn't accept not to get pregnant during the study Known hypersensitivity to active ingredients (including their derivatives) of the study medication Postmenopausal women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule<br>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<br>* Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 0-72 hours | 
| T1/2 | Half-life for each analyte | 0-72 hours | 
| Lambda-z | Elimination rate constant for each analyte | 0-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fenticonazole nitrate, tinidazole, lidocaine, fixed-dose combination