Neoplasms

Blood and Lymph Conditions

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Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Subjects receive CTTQ dasatinib tablet under fasting/fed

Subjects receive Sprycel under fasting/fed

Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.

CTTQ Dasatinib tablet

Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.

Sprycel Dasatinib tablet

This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb after single dose in healthy subjects, so as to provide reference for clinical evaluation and clinical medication; to observe the safety of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.

A Bioequivalence Study of Dasatinib Tablet

A Bioequivalence Study Between the Generic Dasatinib Tablet and Reference Product in Vivo

Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

Area under the plasma concentration-time curve from time zero to time t is a Pharmacokinetic parameter

The area under the plasma concentration curve from 0 to infinity

Time to reach maximum (peak) plasma concentration following drug administration

The time required for the highest concentration of the drug in plasma to decrease by half

Terminal disposition rate constant/terminal rate constant

Apparent volume of distribution after oral administration

Apparent total clearance of the drug from plasma after oral administration

Bioavailability (systemic availability of the administered dose)

Adverse events of subjects occured during the trial

Serious Adverse events of subjects occured during the trial

Monitor the body temperature of subjects and report abnormal body temperature

Monitor the pulse of subjects and report abnormal pulse

Monitor the blood pressure of subjects and report abnormal blood pressure

The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)

laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Bioequivalence Study of Dasatinib Tablet	NCT05640804	Leukemia, Myelo...	CTTQ Dasatinib ... Sprycel Dasatin...	18 Years - 55 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Bioequivalence Study of Dasatinib Tablet	NCT05640804	Leukemia, Myelo...	CTTQ Dasatinib ... Sprycel Dasatin...	18 Years - 55 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Bioequivalence Study of Dasatinib Tablet	NCT05640804	Leukemia, Myelo...	CTTQ Dasatinib ... Sprycel Dasatin...	18 Years - 55 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Bioequivalence Study of Dasatinib Tablet	NCT05640804	Leukemia, Myelo...	CTTQ Dasatinib ... Sprycel Dasatin...	18 Years - 55 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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