NCT04476719

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

June 1, 2020

Enrollment Period

13 days

First QC Date

July 15, 2020

Last Update Submit

July 15, 2020

Conditions

Bioequivalence

Keywords

COVID-19 drug treatmentAntiviral AgentsUmifenovirNovagenixFarmagenAtabay

Outcome Measures

Primary Outcomes (2)

  • Primary PK Endpoint

    AUC0-tlast umifenovir

    12 weeks

  • Primary PK Endpoint

    Cmax of umifenovir

    13 weeks

Secondary Outcomes (3)

  • Secondary PK Endpoint

    14 weeks

  • Secondary PK Endpoint

    15 weeks

  • Secondary PK Endpoint

    16 weeks

Study Arms (2)

Atafenovir 200 mg Kapsül

EXPERIMENTAL

Capsules containing 207.009 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride (Atabay-Turkey).

Drug: ATAFENOVIR 200 MG KAPSUL

Arbidol 100 mg Kapsül

ACTIVE COMPARATOR

Capsules containing 103.504 umifenovir hydrochloride monohydrate equivalent to 100 mg umifenovir hydrochloride (OTC-Pharma Russia).

Drug: ARBIDOL 100 MG KAPSUL

Interventions

ATAFENOVIR 200 MG KAPSULDRUG

A 200 mg capsule 0ral administration with 240 ml water

Also known as: Test Drug
Atafenovir 200 mg Kapsül
ARBIDOL 100 MG KAPSULDRUG

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

Also known as: Reference Drug
Arbidol 100 mg Kapsül

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Caucasian male subjects aged between 20 and 40 years,
  • Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period,
  • Two Negative Covid-19 PCR test results.
  • Negative alcohol breath test results,
  • Normal physical examination at screening visit,
  • Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age,
  • Ability to communicate adequately with the investigator himself or his representatives,
  • Ability and agreement to comply with the study requirements,
  • Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm,
  • Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest,
  • Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate),
  • Understanding of the study and agreement to give a written informed consent.

You may not qualify if:

  • Who have atopic constitution or asthma or known allergy for umifenovir and/or any other ingredients of the products.
  • Who have positive Covid-19 PCR test result.
  • Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
  • Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator),
  • Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
  • Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration.
  • Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement.
  • Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product).
  • Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  • History of allergic response to heparin.
  • Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
  • Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day.
  • Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.
  • History of drug abuse.
  • History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novagenix Drug R&D Center

Akyurt, Ankara, 06970, Turkey (Türkiye)

Location

Farmagen Ar-Ge Biyot. Ltd. Sti.

Şahinbey, Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Drug Evaluationumifenovir

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Muradiye Nacak, MD,PhD

    Farmagen Ar-Ge Biyot. Ltd. Sti

    PRINCIPAL INVESTIGATOR

  • Taner Ezgi, MD

    Farmagen Ar-Ge Biyot. Ltd. Sti

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

July 9, 2020

Primary Completion

July 22, 2020

Study Completion

August 20, 2020

Last Updated

July 20, 2020

Record last verified: 2020-06

Locations

TU(2)