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Clinical Trial Summary

This is a randomized, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of BR9003 and BR9003A in healthy adult subjects. Within each period, randomized subjects will be taken 2 dosing regimens of administrating BR9003 once a day for six days or BR9003A twice a day for six days.

Clinical Trial Description

*Study Objective: After repeated administration of BR9003 2mg and BR9003A 1mg for healthy adult volunteers, the pharmacokinetic properties and safety are evaluated. - Target number of subjects for enrollment (randomization): 24 subjects in total (2 sequence groups(A or B), 12 subjects per sequence group) - Investigational Product 1. Control drug: BR9003A 1mg 2. Test drug: BR9003 2mg - Regimen 1. Control group: Administration of BR9003A 1mg twice a day for six days 2. Test group: Administration of BR9003 2mg once a day for six days ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04857047
Study type Interventional
Source Boryung Pharmaceutical Co., Ltd
Contact Bong-seog Kim
Phone +827088204
Email [email protected]
Status Recruiting
Phase Phase 1
Start date March 31, 2021
Completion date June 2021

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