Kyungpook National University Hospital
Daegu, 700-721, South Korea
NCT Number: NCT02205190
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin in healthy male volunteers
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Daegu, 700-721, South Korea
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of 1 Group take fimasartan and rosuvastatin at 1st day and subjects of 2 Group take fimasartan/rosuvastatin combination at 1st day.
And then, after wash out for 7 days, as period II, subjects of 1 Group take fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and rosuvastatin at 8th day.
At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).
At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 0~72 hour after medication
Time frame: 0~72 hour after medication
Time frame: 0~72 hour after medication
Time frame: 0~72 hour after medication
Time frame: 0~72 hour after medication
Boryung Pharmaceutical Co., Ltd
Industry
A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers
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