A Bioequivalence Study of Sunitinib Malate Capsules.

NCT05800106 | Completed Phase 1

• 1 other identifier: ZDTQ-BE-2018-SNTN
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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, respectively.

Conditions

Gastrointestinal Stromal Tumors; Renal Cell Carcinoma; Pancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (8)

• Maximum plasma concentration (Cmax)

  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 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)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (11)

• Incidence of adverse events (AE)

  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)

  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

  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

  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

  From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.

Study Arms (2)

Sunitinib malate capsules generic product

EXPERIMENTAL

Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively.

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.

Drug: Sunitinib malate capsules reference product

Interventions

Sunitinib malate capsules generic product DRUG

Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).

Sunitinib malate capsules generic product

Sunitinib malate capsules reference product DRUG

Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).

Sunitinib malate capsules reference product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Adenoma, Islet Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenoma; Pancreatic Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: December 4, 2018
• Primary Completion: January 6, 2019
• Study Completion: January 12, 2019
• Last Updated: April 10, 2023

Record last verified: 2018-08

Locations

CN (1)