A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers

NCT05068193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-04-20

No results posted yet for this study

Summary

A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers

Conditions

Interventions

DRUG

BR2008-1 (R)

After fasting at least 10 hours, two tablets of BR2008-1 will be administered orally with 150mL of water around 8 a.m.

DRUG

BR2008 (T)

After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2021-11-28
Completion
2022-01-06

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 NCT05068193 on ClinicalTrials.gov