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Bioequivalence Study of Feniramidol HCl 400 mg Film Tablet (Pharmactive, Turkey) Under Fed Conditions

NCT04639869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-09-28

No results posted yet for this study

Summary

OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS

Conditions

  • Bioequivalence

Interventions

DRUG

Phenyramydol HCl 400 mg Film Tablet

Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S

DRUG

Cabral 400 mg Film Tablet

Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.

Sponsors & Collaborators

  • Novagenix Bioanalytical Drug R&D Center

    collaborator NETWORK

  • Farmagen Ar-Ge Biyot. Ltd. Sti

    collaborator NETWORK

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Muradiye Nacak, MD,PhD · Farmagen Ar-Ge Biyot. Ltd. Sti

  • Taner Ezgi, MD · Farmagen Ar-Ge Biyot. Ltd. Sti

  • Hakan Gürpınar, MSc · Pharmactive İlaç San.ve Tic.A.S

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2019-07-26
Completion
2019-08-27

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 NCT04639869 on ClinicalTrials.gov