A Bioequivalence Study of Dasatinib Tablet

December 7, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CTTTQ Dasatinib tablet
Subjects receive CTTQ dasatinib tablet under fasting/fed
Drug: CTTQ Dasatinib tablet
Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.
Experimental: Sprycel Sprycel
Subjects receive Sprycel under fasting/fed
Drug: Sprycel Dasatinib tablet
Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum (peak) plasma drug concentration (Cmax)
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.
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)
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.
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-∞)
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to maximum concentration (Tmax)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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
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.
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
Time Frame: Up to day 11
Adverse events of subjects occured during the trial
Up to day 11
Serious Adverse Event
Time Frame: Up to day 11
Serious Adverse events of subjects occured during the trial
Up to day 11
Body temperature
Time Frame: Up to day 11
Monitor the body temperature of subjects and report abnormal body temperature
Up to day 11
Pulse
Time Frame: Up to day 11
Monitor the pulse of subjects and report abnormal pulse
Up to day 11
Blood pressure
Time Frame: Up to day 11
Monitor the blood pressure of subjects and report abnormal blood pressure
Up to day 11
CTCAE v5.0
Time Frame: Up to day 11
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
Time Frame: Up to day 11
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
Up to day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZDTQ-BE-2017-DSTN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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