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Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)

NCT04494191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-07-31

No results posted yet for this study

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)

Conditions

  • Healthy

Interventions

DRUG

Flibanserin 100Mg Tab

One tablet contains 100 mg Flibanserin

DRUG

Flibanserin 100 MG [Addyi]

One tablet contains 100 mg Flibanserin

Sponsors & Collaborators

  • Bio Med for Pharmaceuticals Industries (BIOMED), Egypt

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2018-12-19
Completion
2019-02-27

Countries

  • Egypt

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 NCT04494191 on ClinicalTrials.gov