MedTrace Logo

Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route

NCT05125627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-11-18

No results posted yet for this study

Summary

This study was designed to assess the bioequivalence of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) versus Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) after a single Vaginal dose in healthy female subjects under fasting conditions.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)

Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

DRUG

Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)

Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Sponsors & Collaborators

  • Joint Stock Company "Farmak"

    lead INDUSTRY

Principal Investigators

  • Vlad Udovytskyi · Joint Stock Company "Farmak"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2019-10-21
Completion
2019-10-21

Countries

  • Jordan

Study Locations

More Related Trials

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 NCT05125627 on ClinicalTrials.gov