Chonbuk National University Hospital
Jeonju, 561-712, South Korea
NCT Number: NCT02496910
This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.
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Notify Me19 year–50 year
Male
Interventional
Phase 1
Jeonju, 561-712, South Korea
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Twinstar 80/5 mg
Other names: Hygroton 25mg
Time frame: 1 month
Yuhan Corporation
Industry
A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers
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