BioequivalencePhase 1UmifenovirNCT04476719
The Bioequivalence Study of Umifenovir 200 mg Capsul (ATABAY, Turkey) Under Fasting Conditions
A Phase 1 study testing ATAFENOVIR 200 MG KAPSUL and ARBIDOL 100 MG KAPSUL in people with Bioequivalence, run by Atabay Kimya Sanayi Ticaret A.S. at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- ATAFENOVIR 200 MG KAPSUL and ARBIDOL 100 MG KAPSUL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 9 Jul 2020to 20 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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).
- Positive blood test for HBV, HCV and HIV.
- Who have relationship to the investigator.
- Who are not suitable to any of inclusion criteria.
- History of difficulty of swallowing.
- Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
- Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
- Special diet due to any reason, e.g. vegetarian.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Novagenix Drug R&D Center
Akyurt, Ankara, 06970
Farmagen Ar-Ge Biyot. Ltd. Sti.
Şahinbey, Gaziantep, 27000
About this study
Official title: Open-Label, Randomised, Single Oral Dose, Two-Period, Cross-Over Trial To Assess The Bioequivalence Of Atafenovir 200 Mg Kapsul In Comparison With Arbidol 100 Mg Kapsul In Healthy Male Subjects Under Fasting Conditions
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.
Read the detailed description
In order to investigate the bioequivalence of all products, the 90% confidence intervals will be calculated for the geometric mean ratios of test and reference for Cmax and AUC0-tlast of umifenovir. These confidence intervals will then be compared with the corresponding acceptance ranges.
In order to achieve a better approximation to a normal distribution, Cmax and AUC0-tlast data for umifenovir will be logarithmically transformed (base e) before analysis. The sources of variation will be treatments, periods, sequences and subjects within the sequence. Evaluation of treatment, period, sequence and subject (nested within sequence) effects at 5% level of significance will be performed. From the result, the two one-sided hypothesis at the 5% level of significance will be tested by constructing the 90% confidence interval for the geometric mean ratios of test/reference products. The confidence interval is calculated by retransformation of the shortest confidence interval for the difference of the ln-transformed mean values. Differences in tmax will be evaluated non-parametrically.
- Conditions
- Bioequivalence
- Being tested
- ATAFENOVIR 200 MG KAPSUL, ARBIDOL 100 MG KAPSUL
- Keywords
- COVID-19 drug treatment, Antiviral Agents, Umifenovir, Novagenix, Farmagen, Atabay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATAFENOVIR 200 MG KAPSULDrug
Also called Test Drug
A 200 mg capsule 0ral administration with 240 ml water
ARBIDOL 100 MG KAPSULDrug
Also called Reference Drug
Two 100 mg capsules will be administrated with 240 ml water orally.
| Study group | Role | What they receive |
|---|---|---|
| Atafenovir 200 mg Kapsül | Experimental | Capsules containing 207.009 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride (Atabay-Turkey). Receives: 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). Receives: Drug: ARBIDOL 100 MG KAPSUL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK Endpoint
AUC0-tlast umifenovir
Measured: 12 weeks
Primary PK Endpoint
Cmax of umifenovir
Measured: 13 weeks
Secondary outcomes (3)
Secondary PK Endpoint
t1/2 of umifenovir
Measured: 14 weeks
Secondary PK Endpoint
tmax of umifenovir
Measured: 15 weeks
Secondary PK Endpoint
AUC0-inf of umifenovir
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start9 Jul 2020
- Primary completion22 Jul 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atabay Kimya Sanayi Ticaret A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Responsible party
- Sponsor
- Investigators
- Muradiye Nacak, MD,PhD, Principal investigator, Farmagen Ar-Ge Biyot. Ltd. StiTaner Ezgi, MD, Study director, Farmagen Ar-Ge Biyot. Ltd. Sti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476719
- Sponsor's protocol ID
- NOV2020/01918
- Acronym
- Umifenovir
- Status last verified
- Jun 2020
- First submitted
- 15 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomised, Single Oral Dose, Two-Period, Cross-Over Trial To Assess The Bioequivalence Of Atafenovir 200 Mg Kapsul In Comparison With Arbidol 100 Mg Kapsul In Healthy Male Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04476719
- Acronym / sponsor ID
- Umifenovir / NOV2020/01918
- Conditions
- Bioequivalence
- Keywords
- COVID-19 drug treatment, Antiviral Agents, Umifenovir, Novagenix, Farmagen, Atabay
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Atabay Kimya Sanayi Ticaret A.S.Industry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 22 Jul 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to investigate the bioequivalence of all products, the 90% confidence intervals will be calculated for the geometric mean ratios of test and reference for Cmax and AUC0-tlast of umifenovir. These confidence intervals will then be compared with the corresponding acceptance ranges.
In order to achieve a better approximation to a normal distribution, Cmax and AUC0-tlast data for umifenovir will be logarithmically transformed (base e) before analysis. The sources of variation will be treatments, periods, sequences and subjects within the sequence. Evaluation of treatment, period, sequence and subject (nested within sequence) effects at 5% level of significance will be performed. From the result, the two one-sided hypothesis at the 5% level of significance will be tested by constructing the 90% confidence interval for the geometric mean ratios of test/reference products. The confidence interval is calculated by retransformation of the shortest confidence interval for the difference of the ln-transformed mean values. Differences in tmax will be evaluated non-parametrically.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atafenovir 200 mg Kapsül | Experimental | Drug: ATAFENOVIR 200 MG KAPSULCapsules containing 207.009 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride (Atabay-Turkey). |
| Arbidol 100 mg Kapsül | Active comparator | Drug: ARBIDOL 100 MG KAPSULCapsules containing 103.504 umifenovir hydrochloride monohydrate equivalent to 100 mg umifenovir hydrochloride (OTC-Pharma Russia). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATAFENOVIR 200 MG KAPSULAlso: Test DrugA 200 mg capsule 0ral administration with 240 ml water | Drug | Atafenovir 200 mg Kapsül |
| ARBIDOL 100 MG KAPSULAlso: Reference DrugTwo 100 mg capsules will be administrated with 240 ml water orally. | Drug | Arbidol 100 mg Kapsül |
Primary outcome
Primary PK Endpoint
Time frame: 12 weeks
AUC0-tlast umifenovir
Primary PK Endpoint
Time frame: 13 weeks
Cmax of umifenovir
3 secondary outcomes
Secondary PK Endpoint
Time frame: 14 weeks
Secondary PK Endpoint
Time frame: 15 weeks
Secondary PK Endpoint
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muradiye Nacak, MD,PhD principal investigator
Farmagen Ar-Ge Biyot. Ltd. Sti
Taner Ezgi, MD study director
Farmagen Ar-Ge Biyot. Ltd. Sti
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATAFENOVIR 200 MG KAPSUL and ARBIDOL 100 MG KAPSUL in people with Bioequivalence, run by Atabay Kimya Sanayi Ticaret A.S. at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary PK Endpoint (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.