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A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers

NCT05102903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-24

No results posted yet for this study

Summary

To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.

Conditions

Interventions

DRUG

BR1016A

All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.

DRUG

BR1016B

All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Seong Dae Kwon · Metro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05102903 on ClinicalTrials.gov