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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTTTQ Dasatinib tablet | Experimental | Subjects receive CTTQ dasatinib tablet under fasting/fed |
|
| Sprycel Sprycel | Experimental | Subjects receive Sprycel under fasting/fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTTQ Dasatinib tablet | Drug | Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma drug concentration (Cmax) | Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | Area under the plasma concentration-time curve from time zero to time t is a Pharmacokinetic parameter | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| The area under the plasma concentration curve from 0 to infinity (AUC0-∞) | The area under the plasma concentration curve from 0 to infinity | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | Time to reach maximum (peak) plasma concentration following drug administration | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36757390 | Derived | Wang Y, Xue J, Su Z, Cui Y, Liu G, Yang W, Liu Z, Chen J, Ren Q, Yu S, Cheng Y, Zhou Y, Wang W, Chen X, Qu D, Deng Q, Zhao Y, Yang H. Pharmacokinetics and safety of dasatinib and its generic: a phase I bioequivalence study in healthy Chinese subjects. Expert Opin Investig Drugs. 2023 Mar;32(3):263-270. doi: 10.1080/13543784.2023.2179481. Epub 2023 Feb 18. |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Sprycel Dasatinib tablet | Drug | Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb. |
|
The time required for the highest concentration of the drug in plasma to decrease by half |
| 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Apparent end elimination rate constant (λz) | Terminal disposition rate constant/terminal rate constant | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution after oral administration | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Apparent total body clearance (CL/F) | Apparent total clearance of the drug from plasma after oral administration | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Relative bioavailability | Bioavailability (systemic availability of the administered dose) | 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration. |
| Adverse Event | Adverse events of subjects occured during the trial | Up to day 11 |
| Serious Adverse Event | Serious Adverse events of subjects occured during the trial | Up to day 11 |
| Body temperature | Monitor the body temperature of subjects and report abnormal body temperature | Up to day 11 |
| Pulse | Monitor the pulse of subjects and report abnormal pulse | Up to day 11 |
| Blood pressure | Monitor the blood pressure of subjects and report abnormal blood pressure | Up to day 11 |
| CTCAE v5.0 | The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination) | Up to day 11 |
| The Number of participants with abnormal laboratory examinations | laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine | Up to day 11 |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |