- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05800106
A Bioequivalence Study of Sunitinib Malate Capsules.
April 6, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Affiliated Hospital of Changchun University of Traditional Chinese Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sunitinib malate capsules generic product
Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively.
|
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
|
Active Comparator: Sunitinib malate capsules reference product
Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively.
|
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 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
|
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)
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
|
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)
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)
|
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)
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
|
Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
|
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
|
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)
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
|
Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
|
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
|
Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Incidence of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) V5.0.
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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.
|
Severity of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
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.
|
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.
|
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.
|
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.
|
The proportion of subjects with abnormal urinalysis results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
The proportion of subjects with abnormal coagulation function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
The proportion of subjects with abnormal thyroid function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
The proportion of subjects with abnormal blood pressure evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
The proportion of subjects with abnormal pulse evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
The proportion of subjects with abnormal body temperature evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
|
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.
|
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.
|
From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2018
Primary Completion (Actual)
January 6, 2019
Study Completion (Actual)
January 12, 2019
Study Registration Dates
First Submitted
March 23, 2023
First Submitted That Met QC Criteria
March 23, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 6, 2023
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Neoplasms, Connective Tissue
- Carcinoma, Renal Cell
- Gastrointestinal Stromal Tumors
- Neuroendocrine Tumors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- ZDTQ-BE-2018-SNTN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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