Overview

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