The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state
Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state
Metrohospital
Anyang, Kyung Gi, South Korea
Area under the plasma concentration versus time curve (AUC)
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
Peak Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
Number of participants with adverse events
Time frame: From study medication dosing day to follow-up period for maximum 7 days from the second period discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.