Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT05361369
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.
Study:
NCT05361369
Study Brief:
Protocol Section:
NCT05361369