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

NCT05361369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

  • Bioavailability

Interventions

DRUG

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine

Sponsors & Collaborators

  • Monitor CRO

    collaborator INDUSTRY

  • Exeltis Turkey

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2022-05-13
Completion
2023-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361369 on ClinicalTrials.gov