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A Bioequivalence Study of Dasatinib Tablet

Primary Purpose

Leukemia, Myelogenous, Chronic

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CTTQ Dasatinib tablet
Sprycel Dasatinib tablet
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myelogenous, Chronic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions; Subjects were able to complete the study according to the requirements of the trial protocol; Subjects have no disease history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders; Healthy male and female subjects at age of 18-55; Male subjects weighted ≥ 50 kg, female subjects weighted ≥ 45kg, and the body mass index (BMI) was18 kg/m2 to 28 kg/m2 (including the cutoff value). Normal or not clinical significant abnormal vital signs, physical examination, laboratory examination, ECG and imaging examination have; The female blood pregnancy test was negative, and the subjects (including male subjects) had no pregnancy plan from 2 weeks before administration to at least 1 month after the last dose of the study drug and voluntarily took effective contraceptive measures. Exclusion Criteria: Subjects with the following diseases or with clinically significant abnormalities in clinical laboratory examinations or other clinical findings of clinical significance (including but not limited to gastrointestinal, kidney, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric, cardiovascular and cerebrovascular diseases); Subjects with known allergies to dasatinib or its excipients; Subjects smoked at least 5 cigarettes per day 3 months before screening; Subjects with a history of drug or alcohol abuse; Subjects who donated blood within 3 months before screening; Subjects who took any drugs that could change liver enzyme activity 28 days before taking the study drug; Subjects who have taken any drugs, vitamin products or herbal medicines within 14 days before clinical trial; Subjects who smoked and drank alcohol during the trial, or performed strenuous exercise before the trial; Subjects have taken the study drug and participated in other drug clinical trials within 2 months before the clinical trial; Subjects with abnormal vital sign results; Subjects with abnormal clinical medical investigation; Subjects who had clinically significant ECG abnormalities; Subjects with abnormal chest X-rays; Subjects with the positive results of Hepatitis (including hepatitis B and C), AIDS, and syphilis; Female subjects who were lactating or serum-positive for pregnancy; Those who screen positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Subjects with acute illnesses that occurred during the screening period or prior to study drug administration; Acute disease occurs during pre-study screening stage or before study medication Subjects with a history of peptic ulcer or intracranial hemorrhage; Subjects had any disease that increased the risk of bleeding, Subjects were unable to comply with ward management regulations; Subjects cannot complete the trial for personal reasons; Subjects judged unsuitable for participating in this trial by other investigators.

Sites / Locations

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CTTTQ Dasatinib tablet

Sprycel Sprycel

Arm Description

Subjects receive CTTQ dasatinib tablet under fasting/fed

Subjects receive Sprycel under fasting/fed

Outcomes

Primary Outcome Measures

Maximum (peak) plasma drug concentration (Cmax)
Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter
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
The area under the plasma concentration curve from 0 to infinity (AUC0-∞)
The area under the plasma concentration curve from 0 to infinity

Secondary Outcome Measures

Time to maximum concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration
Elimination half-life (t1/2)
The time required for the highest concentration of the drug in plasma to decrease by half
Apparent end elimination rate constant (λz)
Terminal disposition rate constant/terminal rate constant
Apparent volume of distribution (Vd/F)
Apparent volume of distribution after oral administration
Apparent total body clearance (CL/F)
Apparent total clearance of the drug from plasma after oral administration
Relative bioavailability
Bioavailability (systemic availability of the administered dose)
Adverse Event
Adverse events of subjects occured during the trial
Serious Adverse Event
Serious Adverse events of subjects occured during the trial
Body temperature
Monitor the body temperature of subjects and report abnormal body temperature
Pulse
Monitor the pulse of subjects and report abnormal pulse
Blood pressure
Monitor the blood pressure of subjects and report abnormal blood pressure
CTCAE v5.0
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
The Number of participants with abnormal laboratory examinations
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine

Full Information

First Posted
November 30, 2022
Last Updated
December 7, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05640804
Brief Title
A Bioequivalence Study of Dasatinib Tablet
Official Title
A Bioequivalence Study Between the Generic Dasatinib Tablet and Reference Product in Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 9, 2018 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelogenous, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTTTQ Dasatinib tablet
Arm Type
Experimental
Arm Description
Subjects receive CTTQ dasatinib tablet under fasting/fed
Arm Title
Sprycel Sprycel
Arm Type
Experimental
Arm Description
Subjects receive Sprycel under fasting/fed
Intervention Type
Drug
Intervention Name(s)
CTTQ Dasatinib tablet
Intervention Description
Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.
Intervention Type
Drug
Intervention Name(s)
Sprycel Dasatinib tablet
Intervention Description
Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.
Primary Outcome Measure Information:
Title
Maximum (peak) plasma drug concentration (Cmax)
Description
Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter
Time Frame
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.
Title
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Description
Area under the plasma concentration-time curve from time zero to time t is a Pharmacokinetic parameter
Time Frame
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.
Title
The area under the plasma concentration curve from 0 to infinity (AUC0-∞)
Description
The area under the plasma concentration curve from 0 to infinity
Time Frame
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.
Secondary Outcome Measure Information:
Title
Time to maximum concentration (Tmax)
Description
Time to reach maximum (peak) plasma concentration following drug administration
Time Frame
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.
Title
Elimination half-life (t1/2)
Description
The time required for the highest concentration of the drug in plasma to decrease by half
Time Frame
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.
Title
Apparent end elimination rate constant (λz)
Description
Terminal disposition rate constant/terminal rate constant
Time Frame
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.
Title
Apparent volume of distribution (Vd/F)
Description
Apparent volume of distribution after oral administration
Time Frame
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.
Title
Apparent total body clearance (CL/F)
Description
Apparent total clearance of the drug from plasma after oral administration
Time Frame
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.
Title
Relative bioavailability
Description
Bioavailability (systemic availability of the administered dose)
Time Frame
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.
Title
Adverse Event
Description
Adverse events of subjects occured during the trial
Time Frame
Up to day 11
Title
Serious Adverse Event
Description
Serious Adverse events of subjects occured during the trial
Time Frame
Up to day 11
Title
Body temperature
Description
Monitor the body temperature of subjects and report abnormal body temperature
Time Frame
Up to day 11
Title
Pulse
Description
Monitor the pulse of subjects and report abnormal pulse
Time Frame
Up to day 11
Title
Blood pressure
Description
Monitor the blood pressure of subjects and report abnormal blood pressure
Time Frame
Up to day 11
Title
CTCAE v5.0
Description
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Time Frame
Up to day 11
Title
The Number of participants with abnormal laboratory examinations
Description
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
Time Frame
Up to day 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions; Subjects were able to complete the study according to the requirements of the trial protocol; Subjects have no disease history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders; Healthy male and female subjects at age of 18-55; Male subjects weighted ≥ 50 kg, female subjects weighted ≥ 45kg, and the body mass index (BMI) was18 kg/m2 to 28 kg/m2 (including the cutoff value). Normal or not clinical significant abnormal vital signs, physical examination, laboratory examination, ECG and imaging examination have; The female blood pregnancy test was negative, and the subjects (including male subjects) had no pregnancy plan from 2 weeks before administration to at least 1 month after the last dose of the study drug and voluntarily took effective contraceptive measures. Exclusion Criteria: Subjects with the following diseases or with clinically significant abnormalities in clinical laboratory examinations or other clinical findings of clinical significance (including but not limited to gastrointestinal, kidney, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric, cardiovascular and cerebrovascular diseases); Subjects with known allergies to dasatinib or its excipients; Subjects smoked at least 5 cigarettes per day 3 months before screening; Subjects with a history of drug or alcohol abuse; Subjects who donated blood within 3 months before screening; Subjects who took any drugs that could change liver enzyme activity 28 days before taking the study drug; Subjects who have taken any drugs, vitamin products or herbal medicines within 14 days before clinical trial; Subjects who smoked and drank alcohol during the trial, or performed strenuous exercise before the trial; Subjects have taken the study drug and participated in other drug clinical trials within 2 months before the clinical trial; Subjects with abnormal vital sign results; Subjects with abnormal clinical medical investigation; Subjects who had clinically significant ECG abnormalities; Subjects with abnormal chest X-rays; Subjects with the positive results of Hepatitis (including hepatitis B and C), AIDS, and syphilis; Female subjects who were lactating or serum-positive for pregnancy; Those who screen positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Subjects with acute illnesses that occurred during the screening period or prior to study drug administration; Acute disease occurs during pre-study screening stage or before study medication Subjects with a history of peptic ulcer or intracranial hemorrhage; Subjects had any disease that increased the risk of bleeding, Subjects were unable to comply with ward management regulations; Subjects cannot complete the trial for personal reasons; Subjects judged unsuitable for participating in this trial by other investigators.
Facility Information:
Facility Name
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Bioequivalence Study of Dasatinib Tablet

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