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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bioavailability
• Intervention / Treatment: Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey
    • Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule; Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Exeltis Turkey
• Collaborators: Monitor CRO

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): May 13, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine; tinidazole; fixed-dose combination; fenticonazole nitrate
• Other Study ID Numbers: MON837.130.6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No