Bioavailability
Conditions
Keywords
fenticonazole nitrate, tinidazole, lidocaine, fixed-dose combination
Brief 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.
Detailed 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.
Interventions
DRUGEVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine
Sponsors
Monitor CRO
Exeltis Turkey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-72 | 0-72 hours | Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations for each analyte |
| Cmax | 0-72 hours | Maximum observed plasma concentration for each analyte |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 0-72 hours | Time to reach maximum plasma concentration for each analyte |
| AUC0-inf | 0-72 hours | Area under the plasma concentration-time profile from time zero to infinity based on observed plasma concentrations for each analyte |
| T1/2 | 0-72 hours | Half-life for each analyte |
| Lambda-z | 0-72 hours | Elimination rate constant for each analyte |
Countries
Turkey (Türkiye)
Outcome results
None listed