BioequivalencePhase 1NCT05218616
The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Aviga, capsules 50 mg / Sutent®, capsules 50 mg and Sutent®, capsules 50 mg / Aviga, capsules 50 mg in people with Bioequivalence, run by JLLC NatiVita at 1 site in Belarus.
Trial summary
The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Aviga, capsules 50 mg / Sutent®, capsules 50 mg and Sutent®, capsules 50 mg / Aviga, capsules 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelarus
- Study dates
- 21 Jan 2022to 3 May 2022
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged between 18 to 55 years (incl).
- Body mass index 18.5-30 kg/m² (incl).
- No signs of acute or chronic disease during the screening.
- Laboratory blood and urine values are within the normal range or within 10% of the normal range of deviations and are considered by researchers to be clinically insignificant.
- Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test).
- No known history of alcohol abuse, intake of fewer than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine, or 50 ml of spirits).
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- No known history of drugs abuse at least 6 months prior to being included in the test (benzodiazepines, opioids, cocaine, barbiturates, marijuana, amphetamine).
- Willingness to comply with the protocol requirements regarding the restriction of the consumption of foods as well as requirements regarding the intake of food, fluids, and physical activity imposed by the study. Xanthine-containing products (coffee, tea (including tutsan tea), chocolate, cola, cacao, energy drinks, etc.) should be excluded from the diet for at least 48 hours before taking the drug. Products containing tobacco, alcohol-containing products and beverages, concentrated fruit and vegetable juices, grapefruit and/or its juice, other citrus fruits and drinks containing quinine, food containing poppy, fatty, spicy and smoked foods should be excluded at least 72 hours before taking the drug. Cruciferous vegetables (broccoli, Brussels sprouts, cauliflower, kohlrabi, as well as white and red cabbage, savoy, and Chinese cabbage) should be excluded at least 7 days before taking the drug.
- Healthy subject according to medical history, physical examination, and assessment of basic vital signs.
- No significant abnormalities on 12-lead ECG.
- No significant abnormalities on the chest X-ray that was performed within 12 months prior to the start of the study.
- Volunteer's consent to use two medically effective methods of contraception, at least one of which is a barrier method (from the date of screening to the completion of the study and within 10 weeks after the last dose of drugs).
- The subject's voluntary willingness to provide written informed consent.
- The ability, at the judgment of the researcher, to follow all the requirements of the protocol.
Who cannot join
- Burdened allergic history.
- Contraindications for use or hypersensitivity to the active substance or excipients that are part of any of the investigational drugs.
- The medical need in taking CYP3A4 inhibitors (ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin), CYP3A4 inducers (rifampicin, dexamethasone, phenytoin, carbamazepine, phenobarbital), within 30 days before the start of the study, including injection of a depot or implant of any drug less than 3 months before the start of the study.
- Use of any over-the-counter or prescription drugs (including vitamins, minerals, herbal drugs, in particular containing tutsan), use of any dietary supplements less than 14 days before the day of taking the study drug, and throughout the study.
- Any medical or surgical intervention in history that could disrupt the activity of the hematopoietic system, gastrointestinal tract, urinary, and other body systems.
- History or presence of significant urinary, cardiovascular, pulmonary, neuroendocrine, immunological, neurological, hematological, gastrointestinal, and other body systems, visual organ, or psychiatric disease or disorder.
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- Any hereditary disease.
- Participation in any clinical studies less than 90 days prior to the beginning of the current clinical study.
- Oncological disease at present or in history.
- Any blood/plasma donation and/or bleeding in the amount of 450 ml, as well as if the volunteers were transfused with whole blood or its components less than 60 days before the start of the study.
- History or presence of clinically significant hemostasiological disorders or bleeding.
- Acute infections less than 4 weeks before the start of the study, as well as a positive test result for HIV, syphilis, HBV, and HCV.
- Positive breath test for alcohol and urinalysis for drugs.
- Swallowing problems in medical history.
- Use of prohibited foods and drinks.
- Subjects with abnormal heart rhythm (HR at rest ≥ 100 bpm or ≤ 50 bpm) and BP (systolic BP ≤100 mmHg or diastolic BP ≤60 mmHg or systolic BP ≥140 mm Hg or diastolic BP ≥ 90 mmHg) on the day of the examination or in the history.
- Difficulty with taking blood for tests.
- The values of the parameters of the laboratory and instrumental findings are beyond the normal range (over 10% of the normal range of deviations) or are considered by researchers to be clinically significant.
- Vegetarianism or any other type of diet.
Trial locations and contacts
1 site in 1 country.
Andrei Shnipov contact
Belarus1 site
National Anti-Doping Laboratory
Lyasny, Minsk Oblast, 223040
Anastasia Teteryukova, MD, Teteryukova.a@antidoping.by
About this study
Official title: Single-dose, Open-label, 2 Periods, 2 Sequences, Randomized Crossover Bioequivalence Study of Aviga 50 mg Capsules (JLLC NATIVITA, Belarus) and Sutent 50 mg Capsules (Pfizer Italia S.R.L.) in Healthy Volunteers Under Fasting Conditions
The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Within the clinical portion of the study, each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code.
- Conditions
- Bioequivalence
- Being tested
- Aviga, capsules 50 mg / Sutent®, capsules 50 mg, Sutent®, capsules 50 mg / Aviga, capsules 50 mg
- Keywords
- Sunitinib, Bioequivalence, Aviga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aviga, capsules 50 mg / Sutent®, capsules 50 mgDrug
Also called The test product / The reference product
Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib / Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib.
Sutent®, capsules 50 mg / Aviga, capsules 50 mgDrug
Also called The reference product / The test product
Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib / Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR | Other | Not described Receives: Drug: Aviga, capsules 50 mg / Sutent®, capsules 50 mg |
| Sequence RT | Other | Not described Receives: Drug: Sutent®, capsules 50 mg / Aviga, capsules 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of sunitinib for the test and the reference products
The maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
AUC0-t of sunitinib for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Secondary outcomes (6)
AUC0-∞ of sunitinib for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Tmax of sunitinib for the test and the reference products
The time to maximum measured plasma concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Kel of sunitinib for the test and the reference products
The elimination rate constant
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
T1/2 of sunitinib for the test and the reference products
Plasma Elimination Half-Life
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
AUCresid of sunitinib for the test and the reference products
Residual area under the pharmacokinetic curve from the time of the last measured concentration to infinite time
Measured: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.
Measured: Up to 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start21 Jan 2022 (estimated)
- Primary completion3 Mar 2022 (estimated)
- Study completion3 May 2022 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JLLC NatiVita
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Anti Doping Laboratory, Belarus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218616
- Sponsor's protocol ID
- BE-50-SNB-2020
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Open-label, 2 Periods, 2 Sequences, Randomized Crossover Bioequivalence Study of Aviga 50 mg Capsules (JLLC NATIVITA, Belarus) and Sutent 50 mg Capsules (Pfizer Italia S.R.L.) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05218616
- Acronym / sponsor ID
- BE-50-SNB-2020
- Conditions
- Bioequivalence
- Keywords
- Sunitinib, Bioequivalence, Aviga
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- JLLC NatiVitaIndustry (pharma, biotech, devices)
- Collaborators
- National Anti Doping Laboratory, Belarus
- Study start
- 21 Jan 2022 (estimated)
- Primary completion
- 3 Mar 2022 (estimated)
- Study completion
- 3 May 2022 (estimated)
- First posted
- 1 Feb 2022 (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.
The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Within the clinical portion of the study, each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence TR | Other | Drug: Aviga, capsules 50 mg / Sutent®, capsules 50 mg |
| Sequence RT | Other | Drug: Sutent®, capsules 50 mg / Aviga, capsules 50 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy men aged between 18 to 55 years (incl).
- Body mass index 18.5-30 kg/m² (incl).
- No signs of acute or chronic disease during the screening.
- Laboratory blood and urine values are within the normal range or within 10% of the normal range of deviations and are considered by researchers to be clinically insignificant.
- Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test).
Key exclusion criteria (19 listed)
- Burdened allergic history.
- Contraindications for use or hypersensitivity to the active substance or excipients that are part of any of the investigational drugs.
- The medical need in taking CYP3A4 inhibitors (ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin), CYP3A4 inducers (rifampicin, dexamethasone, phenytoin, carbamazepine, phenobarbital), within 30 days before the start of the study, including injection of a depot or implant of any drug less than 3 months before the start of the study.
- Use of any over-the-counter or prescription drugs (including vitamins, minerals, herbal drugs, in particular containing tutsan), use of any dietary supplements less than 14 days before the day of taking the study drug, and throughout the study.
- Any medical or surgical intervention in history that could disrupt the activity of the hematopoietic system, gastrointestinal tract, urinary, and other body systems.
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 |
|---|---|---|
| Aviga, capsules 50 mg / Sutent®, capsules 50 mgAlso: The test product / The reference productAviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib / Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib. | Drug | Sequence TR |
| Sutent®, capsules 50 mg / Aviga, capsules 50 mgAlso: The reference product / The test productSutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib / Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib | Drug | Sequence RT |
Primary outcome
Cmax of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
6 secondary outcomes
AUC0-∞ of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Tmax of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Kel of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
T1/2 of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
AUCresid of sunitinib for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Time frame: Up to 39 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
Andrei Shnipov contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aviga, capsules 50 mg / Sutent®, capsules 50 mg and Sutent®, capsules 50 mg / Aviga, capsules 50 mg in people with Bioequivalence, run by JLLC NatiVita at 1 site in Belarus.
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 14 inclusion and 19 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. 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?
Contact Nadia Malich (+375291093700, nadzeya.malich@nativita.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of sunitinib for the test and the reference products (time frame: Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing). 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 1 Feb 2022.