A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects

NCT05460364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and compare the safety and tolerability after repeated separate or combined administrations of BR1018-1 and BR1018-2 in healthy adults.

Conditions

Interventions

DRUG

BR1018-1

Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days. Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.

DRUG

BR1018-2

Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days. Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

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
2022-08-04
Primary Completion
2022-10-17
Completion
2022-10-17

Countries

  • South Korea

Study Locations

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Entities

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 NCT05460364 on ClinicalTrials.gov