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A Bioequivalence Study of Dasatinib Tablet

NCT05640804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-12-08

No results posted yet for this study

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

Interventions

DRUG

CTTQ Dasatinib tablet

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

DRUG

Sprycel Dasatinib tablet

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

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-09
Primary Completion
2018-10-03
Completion
2019-10-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640804 on ClinicalTrials.gov