NCT04857047

A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects

A Randomized, Open-label, Multiple Doses, Crossover Clinical Study to Compare the Pharmacokinetic Characteristics and the Safety Between Administration of BR9003 and BR9003A in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	BR9003 2mg	After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003 tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it.
DRUG	BR9003A 1mg	After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003A tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it. Another BR9003A tablet will be administered orally with water 150mL around 20:30 after dinner between 18-19:00.

Timeline

• Start date: 2021-03-31
• Primary completion: 2021-06-15
• Completion: 2021-06-28
• First posted: 2021-04-23
• Last updated: 2021-08-18

Locations

1 site across 1 country: South Korea