A Bioequivalence Study of Dasatinib Tablet

NCT ID: NCT05640804

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-09
• Study Completion Date: 2019-10-08

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.

Conditions

Leukemia, Myelogenous, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CTTTQ Dasatinib tablet

Subjects receive CTTQ dasatinib tablet under fasting/fed

Group Type: EXPERIMENTAL

CTTQ Dasatinib tablet

Intervention Type: DRUG

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

Sprycel Sprycel

Subjects receive Sprycel under fasting/fed

Group Type: EXPERIMENTAL

Sprycel Dasatinib tablet

Intervention Type: DRUG

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

Interventions

CTTQ Dasatinib tablet

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

Intervention Type: DRUG

Sprycel Dasatinib tablet

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36757390 (View on PubMed)

Other Identifiers

ZDTQ-BE-2017-DSTN

Identifier Type: -

Identifier Source: org_study_id