A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
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|ClinicalTrials.gov Identifier: NCT02569814|
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Hyperlipidemia||Drug: Fimasartan/Amlodipine/Rosuvastatin Drug: Fimasartan/Amlodipine Drug: Rosuvastatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
- Cmax of Fimasartan, Amlodipine and Rosuvastatin [ Time Frame: 0~144 hour after medication ]
- AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin [ Time Frame: 0~144 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): NCT02569814
|Korea, Republic of|
|Inje University Busan Paik Hospital|
|Busan, Korea, Republic of|