CHA Bundang Medical Center(CBMC)
Seongnam-si, Gyeonggi-do, South Korea
NCT Number: NCT05951946
The purpose of this clinical trial is to evaluate drug-drug interactions and safety between "BR3006-1", "BR3006-2", and "BR3006-3" in healthy volunteers
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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Seongnam-si, Gyeonggi-do, South Korea
A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C,D,E,F) assigned to each sequence group in Period 1, Period 2 and Period 3.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Time frame: Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period
Area under the concentration-time curve from time zero to time τ of BR3006-1, BR3006-2 and BR3006-3 at steady-state
Time frame: Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period
Maximum concentration of drug in plasma of BR3006-1, BR3006-2 and BR3006-3 at steady-state
Boryung Pharmaceutical Co., Ltd
Industry
An Open Label, 6-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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