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Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects

NCT05125640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-11-18

No results posted yet for this study

Summary

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

Conditions

  • Pharmacokinetics

Interventions

DRUG

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

Orally, with 240 mL of water at dosing in sitting position

DRUG

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

Orally, with 240 mL of water at dosing in sitting position

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
2019-12-13
Primary Completion
2020-01-07
Completion
2020-01-07

Countries

  • Jordan

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 NCT05125640 on ClinicalTrials.gov