NCT05640804

A Bioequivalence Study of Dasatinib Tablet

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-09-09
• Primary completion: 2018-10-03
• Completion: 2019-10-08
• First posted: 2022-12-07
• Last updated: 2022-12-08

Locations

1 site across 1 country: China