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

• Sponsor: Exeltis Turkey (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05361369
• Collaborator: Monitor CRO (Industry)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.8
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability	Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: May 9, 2022
• Actual Primary Completion Date: May 13, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Cmax [0-72 hours]

   Maximum observed plasma concentration for each analyte

Secondary Outcome Measures

1. Tmax [0-72 hours]

   Time to reach maximum plasma concentration for each analyte

2. 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

3. T1/2 [0-72 hours]

   Half-life for each analyte

4. Lambda-z [0-72 hours]

   Elimination rate constant for each analyte

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)	Kayseri		Turkey

Sponsors and Collaborators

• Exeltis Turkey
• Monitor CRO

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exeltis Turkey
• ClinicalTrials.gov Identifier: NCT05361369
• Other Study ID Numbers: MON837.130.6
• First Posted: May 4, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Exeltis Turkey: fenticonazole nitrate; tinidazole; lidocaine; fixed-dose combination

Study Results

No Results Posted as of Jul 28, 2022