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

NCT05361369 | Completed Phase 1

• 1 other identifier: MON837.130.6
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

fenticonazole nitrate; tinidazole; lidocaine; fixed-dose combination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Tmax

  0-72 hours

• AUC0-inf

  0-72 hours

• T1/2

  0-72 hours

• Lambda-z

  0-72 hours

Study Arms (1)

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

EXPERIMENTAL

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

Interventions

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule DRUG

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

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Exeltis Turkey: lead
• Monitor CRO: collaborator

Study Sites (1)

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

Kayseri, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: May 9, 2022
• Primary Completion: May 13, 2022
• Study Completion: March 15, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)