EVEGYN Vaginal Ovule Bioavailability Study in Healthy Female Subjects
This study aims to evaluate the bioavailability of the EVEGYN Vaginal Ovule in healthy female subjects, by measuring the maximum observed plasma concentration and the area under the plasma concentration-time profile from time zero to 72 hours post dose for each analyte.
EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Other Study
Summary
Study start date: May 9, 2022
Actual date on which the first participant was enrolled.This study focuses on a medication called EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, a combination of three drugs: 600 mg fenticonazole nitrate, 1000 mg tinidazole, and 100 mg lidocaine. This medication is designed to combat common vaginal infections like bacterial vaginosis and candidal vulvovaginitis. The study aims to understand how this medication works in the body and how safe it is. It's being conducted with 18 healthy female participants, as the medication is intended for women's health. The results of this study could help improve treatment options for common vaginal infections. In this study, each participant receives a single dose of the medication, which is administered intravaginally. The study then measures how the body responds to each of the three drugs in the medication over a period of 72 hours. The response is measured by looking at the maximum concentration of each drug in the bloodstream and the area under the plasma concentration-time curve, which shows how the concentration of the drug changes over time. This helps researchers understand how the body absorbs and processes the medication.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Kayseri, Turkey (Türkiye)Open Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) in Google Maps