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A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects

NCT04857047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-08-18

No results posted yet for this study

Summary

This is a randomized, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of BR9003 and BR9003A in healthy adult subjects. Within each period, randomized subjects will be taken 2 dosing regimens of administrating BR9003 once a day for six days or BR9003A twice a day for six days.

Conditions

  • Smoking Cessation

Interventions

DRUG

BR9003 2mg

After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003 tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it.

DRUG

BR9003A 1mg

After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003A tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it. Another BR9003A tablet will be administered orally with water 150mL around 20:30 after dinner between 18-19:00.

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
2021-03-31
Primary Completion
2021-06-15
Completion
2021-06-28

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 NCT04857047 on ClinicalTrials.gov