A Bioequivalence Study of Dasatinib Tablet

Leukemia, Myelogenous, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640804
• Other study ID #: ZDTQ-BE-2017-DSTN
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: July 2018
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 8, 2019
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Myelogenous, Chronic
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• CTTQ Dasatinib tablet
Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.
• Sprycel Dasatinib tablet
Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.

Locations

Country	Name	City	State
China	Affiliated Hospital of Changchun University of Traditional Chinese Medicine	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	The area under the plasma concentration curve from 0 to infinity (AUC0-8)	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	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.
Secondary	Elimination half-life (t1/2)	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.
Secondary	Apparent end elimination rate constant (?z)	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Adverse Event	Adverse events of subjects occured during the trial	Up to day 11
Secondary	Serious Adverse Event	Serious Adverse events of subjects occured during the trial	Up to day 11
Secondary	Body temperature	Monitor the body temperature of subjects and report abnormal body temperature	Up to day 11
Secondary	Pulse	Monitor the pulse of subjects and report abnormal pulse	Up to day 11
Secondary	Blood pressure	Monitor the blood pressure of subjects and report abnormal blood pressure	Up to day 11
Secondary	CTCAE v5.0	The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)	Up to day 11
Secondary	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