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Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions

NCT04400682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-08-11

Study results available
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Summary

A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions with current pandemic precautions.

Conditions

  • Bioequivalence

Interventions

DRUG

FAVIRA 200 MG Film Tablet

FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.

DRUG

AVIGAN 200 MG Film Tablets

AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan

Sponsors & Collaborators

  • Novagenix Bioanalytical Drug R&D Center

    collaborator NETWORK

  • Farmagen Ar-Ge Biyot. Ltd. Sti

    collaborator NETWORK

  • Novelfarma Ilaç San. ve Tic. Ltd. Sti.

    lead INDUSTRY

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2020-06-05
Completion
2020-06-18

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 NCT04400682 on ClinicalTrials.gov