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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Exeltis Turkey
• Collaborator: Monitor CRO

Criteria

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