NCT04846998

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

A Randomized, Open-label, Three-treatment, Six-sequence, Three-period, Crossover Clinical Study to Compare the Pharmacokinetic Characteristics Between Twice Daily Administration of BR9003A and Once Daily Administration of BR9003 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9003 compared with BR9003A in healthy adult subjects

Detailed description

A total of 24 subjects will be randomized into 6 sequence groups. The Investigational Products wil be according to the treatment group (A,B,C) assigned to each sequence group in Period 1, Period 2 and Period 3.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	BR9003	Treatment group B: Once-daily oral administration of one BR9003 2mg tablet in the fasting state. Treatment group C: Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it.
DRUG	BR9003A	Treatment group A: Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-05-04
• Completion: 2021-05-18
• First posted: 2021-04-15
• Last updated: 2021-07-20

Locations

1 site across 1 country: South Korea