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

Exeltis Turkey18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bioavailability

Interventions

EVEGYN 600 mg/1000 mg/100 mg Vaginal OvuleDRUG

Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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