Clinical trial NCT05640804: A Bioequivalence Study of Dasatinib Tablet
Official title: A Bioequivalence Study Between the Generic Dasatinib Tablet and Reference Product in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myelogenous, Chronic
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum (peak) plasma drug concentration (Cmax)
timeFrame: 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: Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
timeFrame: 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: The area under the plasma concentration curve from 0 to infinity (AUC0-∞)
timeFrame: 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:
measure: Time to maximum concentration (Tmax)
timeFrame: 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: Elimination half-life (t1/2)
timeFrame: 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: Apparent end elimination rate constant (λz)
timeFrame: 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: Apparent volume of distribution (Vd/F)
timeFrame: 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: Apparent total body clearance (CL/F)
timeFrame: 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: Relative bioavailability
timeFrame: 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: Adverse Event
timeFrame: Up to day 11
measure: Serious Adverse Event
timeFrame: Up to day 11
measure: Body temperature
timeFrame: Up to day 11
measure: Pulse
timeFrame: Up to day 11
measure: Blood pressure
timeFrame: Up to day 11
measure: CTCAE v5.0
timeFrame: Up to day 11
measure: The Number of participants with abnormal laboratory examinations
timeFrame: Up to day 11
Other outcomes:
Locations:
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of Traditional Chinese Medicine
state: Jilin
Study officials:
References: