Gastrointestinal Stromal TumorsPhase 1NCT05800106
A Bioequivalence Study of Sunitinib Malate Capsules.
A Phase 1 study testing Sunitinib malate capsules generic product and Sunitinib malate capsules reference product in people with Gastrointestinal Stromal Tumors and Renal Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Stromal Tumors, Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor
- What is being tested?
- Sunitinib malate capsules generic product and Sunitinib malate capsules reference product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2018to 12 Jan 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The informed consent was signed before the study, fully understood the content and process of the study and the potential adverse reactions.
- Ability to complete the study in accordance with the protocol requirements.
- Chinese healthy adults aged 18-45 (included), male.
- Weight not less than 50 kg with a body mass index (BMI) between 18 and 28 kg/m2 (included, BMI = weight /height2).
- Health status: No mental abnormalities, no medical history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
- Vital signs, physical examination, laboratory examination, electrocardiogram and imaging examinations should be normal or abnormal with no clinical significance.
- Volunteers (including the partner) should ensure proper contraception from 2 weeks before dosing to at least 6 months after the last study drug administration, and ensure that one or more contraception measures are used in sexual during this period.
Who cannot join
- Previously suffered from neuropsychiatric system, respiratory system, cardiovascular system, gastrointestinal system, hemolymphatic system, liver and kidney insufficiency, endocrine system, musculoskeletal system diseases or other diseases, and the investigator judges that the past medical history may affect drug metabolism or safety.
- History of dysphagia or any gastrointestinal disorder affecting drug absorption.
- Have a history of intracranial hemorrhage or any disease that increases the risk of bleeding (such as repeated rhinorrhea, purpura, hemorrhoids, acute gastritis, etc.).
- Male subjects with clinically significant abnormal ECG history, or corrected QT (QTC) interval greater than 450 ms.
- People who have a history of dizziness of needles or blood.
- People who are allergic to sunitinib malate and its metabolites or its excipients.
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- People who smoked more than 5 cigarettes per day in the 3 months before the clinical trial.
- People who have a history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine).
- Blood donation or massive blood loss (> 450mL) within 2 months before taking study drug.
- Taking any drugs and contraceptives that change the activity of liver enzymes within 28 days before the study drug administration (such as liver drug enzyme inhibitors chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducers barbiturates, carbamazepine, rifampicin, dexamethasone, etc.).
- Taking any prescription drug, over-the-counter drug, any vitamin product, or herbal remedies within 14 days prior to the study drug administration.
- Need to use tobacco, alcohol and caffeinated drinks during the clinical trial, or certain foods that may affect metabolism (including dragon fruit, mango, grapefruit, and/or xanthine diet, etc.), or have significant changes in diet or exercise habits before the clinical trial , or other factors that affect drug absorption, distribution, metabolism, excretion, etc.
- Taking any study drug or participated in another drug clinical trial within 2 months before the study drug administration.
- Abnormal vital sign examination results with clinically significance.
- Abnormal clinical laboratory tests with clinically significance.
- Abnormal chest x-ray with clinically significance.
- Screening positive for hepatitis (including hepatitis B and C), Acquired immunodeficiency syndrome (AIDS), and syphilis.
- People who were positive in drug screening or had a history of drug abuse in the past five years or used drugs in the 3 months before the clinical trial.
- Difficulty or intolerance to blood collection by venipuncture.
- Acute illness occurred during the pre-study screening phase or prior to study medication.
- People who are unable to comply with ward management regulations.
- People who are unable to complete the clinical trial due to personal reasons.
- Other conditions that the investigator judges are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
Official title: A Bioequivalence Study of Sunitinib Malate Capsules in Healthy Volunteers Under Fed Condition.
A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.
- Being tested
- Sunitinib malate capsules generic product, Sunitinib malate capsules reference product
- Medical subject headings
- Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib malate capsules generic productDrug
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
Sunitinib malate capsules reference productDrug
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib malate capsules generic product | Experimental | Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. Receives: Drug: Sunitinib malate capsules generic product |
| Sunitinib malate capsules reference product | Active comparator | Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. Receives: Drug: Sunitinib malate capsules reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Maximum plasma concentration
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Time to maximum concentration (Tmax)
Time to reach maximum concentration after drug administration
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Area under the drug-time curve (AUC)
Area under the drug-time curve
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination half-life (t1/2)
Apparent terminal elimination half-life (t1/2)
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Clearance rate (CL/F)
Clearance rate
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination rate constant (λz)
Apparent terminal elimination rate constant
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Relative bioavailability (F)
Relative bioavailability (F) of the tested product to reference product
Measured: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Secondary outcomes (11)
Incidence of adverse events (AE)
Incidence of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) V5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Severity of adverse events (AE)
Severity of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood biochemistry results
The proportion of subjects with abnormal blood biochemistry results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood routine
The proportion of subjects with abnormal blood routine results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal urinalysis results
The proportion of subjects with abnormal urinalysis results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal coagulation function
The proportion of subjects with abnormal coagulation function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal thyroid function
The proportion of subjects with abnormal thyroid function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood pressure
The proportion of subjects with abnormal blood pressure evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal pulse
The proportion of subjects with abnormal pulse evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal body temperature
The proportion of subjects with abnormal body temperature evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal 12-lead electrocardiogram (ECG)
The proportion of subjects with abnormal 12-lead ECG evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Measured: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start4 Dec 2018
- Primary completion6 Jan 2019
- Study completion12 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800106
- Sponsor's protocol ID
- ZDTQ-BE-2018-SNTN
- Status last verified
- Aug 2018
- First submitted
- 23 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Sunitinib Malate Capsules in Healthy Volunteers Under Fed Condition.
- ClinicalTrials.gov ID
- NCT05800106
- Acronym / sponsor ID
- ZDTQ-BE-2018-SNTN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 12 Jan 2019 (actual)
- First posted
- 5 Apr 2023 (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 randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunitinib malate capsules generic product | Experimental | Drug: Sunitinib malate capsules generic productSingle dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. |
| Sunitinib malate capsules reference product | Active comparator | Drug: Sunitinib malate capsules reference productSingle dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The informed consent was signed before the study, fully understood the content and process of the study and the potential adverse reactions.
- Ability to complete the study in accordance with the protocol requirements.
- Chinese healthy adults aged 18-45 (included), male.
- Weight not less than 50 kg with a body mass index (BMI) between 18 and 28 kg/m2 (included, BMI = weight /height2).
- Health status: No mental abnormalities, no medical history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
Key exclusion criteria (23 listed)
- Previously suffered from neuropsychiatric system, respiratory system, cardiovascular system, gastrointestinal system, hemolymphatic system, liver and kidney insufficiency, endocrine system, musculoskeletal system diseases or other diseases, and the investigator judges that the past medical history may affect drug metabolism or safety.
- History of dysphagia or any gastrointestinal disorder affecting drug absorption.
- Have a history of intracranial hemorrhage or any disease that increases the risk of bleeding (such as repeated rhinorrhea, purpura, hemorrhoids, acute gastritis, etc.).
- Male subjects with clinically significant abnormal ECG history, or corrected QT (QTC) interval greater than 450 ms.
- People who have a history of dizziness of needles or blood.
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 |
|---|---|---|
| Sunitinib malate capsules generic productSunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK). | Drug | Sunitinib malate capsules generic product |
| Sunitinib malate capsules reference productSunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK). | Drug | Sunitinib malate capsules reference product |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Maximum plasma concentration
Time to maximum concentration (Tmax)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Time to reach maximum concentration after drug administration
Area under the drug-time curve (AUC)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Area under the drug-time curve
Apparent terminal elimination half-life (t1/2)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination half-life (t1/2)
Apparent volume of distribution (Vd/F)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent volume of distribution
Clearance rate (CL/F)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Clearance rate
Apparent terminal elimination rate constant (λz)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination rate constant
Relative bioavailability (F)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Relative bioavailability (F) of the tested product to reference product
11 secondary outcomes
Incidence of adverse events (AE)
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Severity of adverse events (AE)
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood biochemistry results
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood routine
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal urinalysis results
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal coagulation function
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal thyroid function
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood pressure
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal pulse
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal body temperature
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal 12-lead electrocardiogram (ECG)
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sunitinib malate capsules generic product and Sunitinib malate capsules reference product in people with Gastrointestinal Stromal Tumors and Renal Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
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 7 inclusion and 23 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: finished, as of the sponsor's last update on 10 Apr 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (Cmax) (time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.). The study lists 8 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 10 Apr 2023.