A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Smoking Cessation
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 55 years
- Gender
- Both males and females
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 gro...
*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 Control drug: BR9003A 1mg Test drug: BR9003 2mg Regimen Control group: Administration of BR9003A 1mg twice a day for six days Test group: Administration of BR9003 2mg once a day for six days
Tracking Information
- NCT #
- NCT04857047
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sang-Heon Cho Inha University Hospital
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