Metrohospital
Anyang, Kyung Gi, 430-720, South Korea
NCT Number: NCT02955498
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.
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Notify Me20 year–45 year
Male
Interventional
Phase 1
Anyang, Kyung Gi, 430-720, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
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)
Time frame: From study medication dosing day to follow-up period for maximum 7 days from the second period discharge
Hanlim Pharm. Co., Ltd.
Industry
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects
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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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