Neoplasms

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Kidney Neoplasms

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Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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All Drugs and Chemicals

Amino Acids

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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).

Sunitinib malate capsules generic product

Sunitinib malate capsules reference product

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.

A Bioequivalence Study of Sunitinib Malate Capsules.

A Bioequivalence Study of Sunitinib Malate Capsules in Healthy Volunteers Under Fed Condition.

Time to reach maximum concentration after drug administration

Apparent terminal elimination half-life (t1/2)

Apparent terminal elimination rate constant

Relative bioavailability (F) of the tested product to reference product

Incidence of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) V5.0.

Severity of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

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.

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.

The proportion of subjects with abnormal urinalysis results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

The proportion of subjects with abnormal coagulation function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

The proportion of subjects with abnormal thyroid function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

The proportion of subjects with abnormal blood pressure evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

The proportion of subjects with abnormal pulse evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

The proportion of subjects with abnormal body temperature evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Bioequivalence Study of Sunitinib Malate Capsules.	NCT05800106	Gastrointestina... Renal Cell Carc... Pancreatic Neur...	Sunitinib malat... Sunitinib malat...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Bioequivalence Study of Sunitinib Malate Capsules.	NCT05800106	Gastrointestina... Renal Cell Carc... Pancreatic Neur...	Sunitinib malat... Sunitinib malat...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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