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

Exeltis

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05361369

MON837.130.6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Experimental group

Description:

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.

Treatment:

Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule