Status:
COMPLETED
Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Lead Sponsor:
Exeltis Turkey
Collaborating Sponsors:
Monitor CRO
Conditions:
Bioavailability
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
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.
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05361369
Start Date
May 9 2022
End Date
March 15 2023
Last Update
February 7 2025
Active Locations (1)
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1
Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Kayseri, Turkey (Türkiye)