NCT04462029

A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers

A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability of BR4002 Comparing to BR4002-1 in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.

Detailed description

A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.

Conditions

• Dementia Alzheimers

Interventions

Type	Name	Description
DRUG	BR4002	* Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours * Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours
DRUG	BR4002-1	Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water

Timeline

• Start date: 2020-06-05
• Primary completion: 2020-10-07
• Completion: 2020-10-07
• First posted: 2020-07-08
• Last updated: 2020-10-28

Locations

1 site across 1 country: South Korea