A Phase 1 interventional study of Fimasartan and Amlodipine in Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1 and Interventional
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.
And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.
At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 86 is close to the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination
Drug: Fimasartan · Drug: Amlodipine · Drug: Fimasartan/Amlodipine combination
Treatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination
Drug: Fimasartan · Drug: Amlodipine · Drug: Fimasartan/Amlodipine combination
(Cmax)
Time frame: 0~144 hour after medication
(AUClast)
Time frame: 0~144 hour after medication
(AUCinf)
Time frame: 0~144 hour after medication
(tmax)
Time frame: 0~144 hour after medication
(t1/2)
Time frame: 0~144 hour after medication
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Boryung Pharmaceutical Co., Ltd