AzTrials
AzTrials

Leukemia, Myelogenous, ChronicPhase 1NCT05640804

A Bioequivalence Study of Dasatinib Tablet

A Phase 1 study testing CTTQ Dasatinib tablet and Sprycel Dasatinib tablet in people with Leukemia, Myelogenous, Chronic, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Leukemia, Myelogenous, Chronic
What is being tested?
CTTQ Dasatinib tablet and Sprycel Dasatinib tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
9 Sep 2018to 8 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: 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.

Being tested
CTTQ Dasatinib tablet, Sprycel Dasatinib tablet
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTTQ Dasatinib tabletDrug

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

  • Sprycel Dasatinib tabletDrug

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

Study groups in NCT05640804
Study groupRoleWhat they receive
CTTTQ Dasatinib tabletExperimentalSubjects receive CTTQ dasatinib tablet under fasting/fed
Receives: Drug: CTTQ Dasatinib tablet
Sprycel SprycelExperimentalSubjects receive Sprycel under fasting/fed
Receives: Drug: Sprycel Dasatinib tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum (peak) plasma drug concentration (Cmax)

    Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

    Measured: 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.

  2. 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

    Measured: 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.

  3. The area under the plasma concentration curve from 0 to infinity (AUC0-∞)

    The area under the plasma concentration curve from 0 to infinity

    Measured: 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 outcomes (13)

  1. Time to maximum concentration (Tmax)

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

    Measured: 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.

  2. Elimination half-life (t1/2)

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

    Measured: 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.

  3. Apparent end elimination rate constant (λz)

    Terminal disposition rate constant/terminal rate constant

    Measured: 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.

  4. Apparent volume of distribution (Vd/F)

    Apparent volume of distribution after oral administration

    Measured: 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.

  5. Apparent total body clearance (CL/F)

    Apparent total clearance of the drug from plasma after oral administration

    Measured: 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.

  6. Relative bioavailability

    Bioavailability (systemic availability of the administered dose)

    Measured: 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.

  7. Adverse Event

    Adverse events of subjects occured during the trial

    Measured: Up to day 11

  8. Serious Adverse Event

    Serious Adverse events of subjects occured during the trial

    Measured: Up to day 11

  9. Body temperature

    Monitor the body temperature of subjects and report abnormal body temperature

    Measured: Up to day 11

  10. Pulse

    Monitor the pulse of subjects and report abnormal pulse

    Measured: Up to day 11

  11. Blood pressure

    Monitor the blood pressure of subjects and report abnormal blood pressure

    Measured: Up to day 11

  12. CTCAE v5.0

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

    Measured: Up to day 11

  13. The Number of participants with abnormal laboratory examinations

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

    Measured: Up to day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start9 Sep 2018
  3. Primary completion3 Oct 2018
  4. Study completion8 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05640804
Sponsor's protocol ID
ZDTQ-BE-2017-DSTN
Status last verified
Jul 2018
First submitted
30 Nov 2022
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36757390

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTTQ Dasatinib tablet and Sprycel Dasatinib tablet in people with Leukemia, Myelogenous, Chronic, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05640804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in