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

Phase 1

Completed

• Conditions: Bioavailability
• Interventions: Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

• Registration Number: NCT05361369
• Lead Sponsor: Exeltis Turkey

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 Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Study Start: 2022-05-09
• Primary Completion: 2022-05-13
• Study Completion: 2023-03-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule	EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
T1/2	0-72 hours	Half-life for each analyte
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
Lambda-z	0-72 hours	Elimination rate constant for each analyte

Trial Locations

Locations (1)

Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP); 🇹🇷 Kayseri, Turkey