A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.

NCT04485585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-28

No results posted yet for this study

Summary

To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.

Conditions

Interventions

DRUG

BR9006-1

* Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose

DRUG

BR9006-2

* Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose * Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • An-Hye Kim · CHA University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2020-08-16
Completion
2020-08-26

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 NCT04485585 on ClinicalTrials.gov