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

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05361369
• Other study ID #: MON837.130.6
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 9, 2022
• Est. completion date: September 2022

Study information

• Verified date: April 2022
• Source: Exeltis Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine

Locations

Country	Name	City	State
Turkey	Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
Exeltis Turkey	Monitor CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cmax	Maximum observed plasma concentration for each analyte	0-72 hours
Secondary	Tmax	Time to reach maximum plasma concentration for each analyte	0-72 hours
Secondary	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
Secondary	T1/2	Half-life for each analyte	0-72 hours
Secondary	Lambda-z	Elimination rate constant for each analyte	0-72 hours