A Bioequivalence Study of Dasatinib Tablet

NCT05640804 | Completed Phase 1

• 1 other identifier: ZDTQ-BE-2017-DSTN
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

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

  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 Outcomes (13)

• Time to maximum concentration (Tmax)

  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)

  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)

  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)

  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)

  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.

Study Arms (2)

CTTTQ Dasatinib tablet

EXPERIMENTAL

Subjects receive CTTQ dasatinib tablet under fasting/fed

Drug: CTTQ Dasatinib tablet

Sprycel Sprycel

EXPERIMENTAL

Subjects receive Sprycel under fasting/fed

Drug: Sprycel Dasatinib tablet

Interventions

CTTQ Dasatinib tablet DRUG

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

CTTTQ Dasatinib tablet

Sprycel Dasatinib tablet DRUG

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

Sprycel Sprycel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 36757390 DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 7, 2022
• Study Start: September 9, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 8, 2019
• Last Updated: December 8, 2022

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)