To Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin
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|ClinicalTrials.gov Identifier: NCT01921946|
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : October 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Fimasartan Drug: Rosuvastatin||Phase 1|
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of Part A take fimasartan for 7 days and subjects of Part B take rosuvastatin for 7 days.
And then, after wash out for 7 days, as period II, subjects of both Part A and B take fimasartan and rosuvastatin for 7 days.
At each period, subjects of Part A have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48hour after medication(17 times in each period, 34 times in total).
At each period, subjects of Part B have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72hour after medication(17 times in each period, 34 times in total).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅰ Study to Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin in Healthy Male Volunteers|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Fimasartan (7 days) → Fimasartan + Rosuvastatin (7 days)
Rosuvastatin (7 days) → Fimasartan + Rosuvastatin (7 days)
- (AUC tau,ss),(Cmax,ss),(Cmin,ss), (Tmax,ss), (t1/2) [ Time Frame: 0~72 hour after medication ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921946
|Korea, Republic of|
|Kyungpook National University Hospital|
|Daegu, Korea, Republic of, 700-721|
|Principal Investigator:||Young Ran Yoon, M.D., Ph.D.||Kyungpook National University Hospital|