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The Bioequivalence Study of Umifenovir 200 mg Capsul (ATABAY, Turkey) Under Fasting Conditions

NCT04476719 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-07-20

No results posted yet for this study

Summary

A single dose of Reference product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride and a single dose of Test product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions with Covid-19 Pandemic precautions.

Conditions

  • Bioequivalence

Interventions

DRUG

ATAFENOVIR 200 MG KAPSUL

A 200 mg capsule 0ral administration with 240 ml water

DRUG

ARBIDOL 100 MG KAPSUL

Two 100 mg capsules will be administrated with 240 ml water orally.

Sponsors & Collaborators

  • Novagenix Bioanalytical Drug R&D Center

    collaborator NETWORK

  • Farmagen Ar-Ge Biyot. Ltd. Sti

    collaborator NETWORK

  • Atabay Kimya Sanayi Ticaret A.S.

    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
2020-07-09
Primary Completion
2020-07-22
Completion
2020-08-20

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 NCT04476719 on ClinicalTrials.gov