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

NCT04462029 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-10-28

No results posted yet for this study

Summary

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

Conditions

  • Dementia Alzheimers

Interventions

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

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Sang-Heon Cho · Inha University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2020-10-07
Completion
2020-10-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462029 on ClinicalTrials.gov