CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13520, South Korea
NCT Number: NCT04485585
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.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Seongnam-si, Gyeonggi-do, 13520, South Korea
A total of 36 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (T, M, T+M) assigned to one 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
Other names: Tamsulosin HCL
Other names: Mirabegron
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Boryung Pharmaceutical Co., Ltd
Industry
An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
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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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