Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT02397590
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.
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Notify Me19 year–50 year
Male
Interventional
Phase 1
Seoul, South Korea
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F
At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).
At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Time Frame: 0~48 hour after medication
Time frame: Time Frame: 0~48 hour after medication
Boryung Pharmaceutical Co., Ltd
Industry
A Randomized, Open-label, Six-sequence, Three-period, Multiple Dosing Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
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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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