The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

Study Overview
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Brief Summary
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A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Detailed Description
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A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Telmisartan/Amlodipine
* Drug: Rosuvastatin and Telmisartan/Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 55 years healthy male Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2 Subjects who agree to keep contraceptive methods during the clinical trial. Exclusion Criteria: Subjects who are allergic to investigational drug. Subjects who have a medical history which can affect the clinical trial. Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg) Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 of part 1<br>Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2 | Drug: Rosuvastatin<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days<br>* Other names: Crestor;Drug: Rosuvastatin and Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days<br>* Other names: Crestor and Twynsta;|
| Experimental: Group 2 of part 1<br>Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2 | Drug: Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days<br>* Other names: Twynsta;Drug: Rosuvastatin and Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days<br>* Other names: Crestor and Twynsta;|
| Experimental: Group 1 of part 2<br>Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2 | Drug: Rosuvastatin<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days<br>* Other names: Crestor;Drug: Rosuvastatin and Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days<br>* Other names: Crestor and Twynsta;|
| Experimental: Group 2 of part 2<br>Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2 | Drug: Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days<br>* Other names: Twynsta;Drug: Rosuvastatin and Telmisartan/Amlodipine<br>* Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days<br>* Other names: Crestor and Twynsta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine |  | 72hours, 144hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast,ss of Rosuvastatin |  | 72hours | 
| AUCinf,ss of Rosuvastatin |  | 72hours | 
| Tmax,ss of Rosuvastatin |  | 72hours | 
| t1/2 of Rosuvastatin |  | 72hours | 
| AUClast,ss of Telmisartan, Amlodipine |  | 144hours | 
| AUCinf,ss of Telmisartan, Amlodipine |  | 144hours | 
| Tmax,ss of Telmisartan, Amlodipine |  | 144hours | 
| t1/2 of Telmisartan, Amlodipine |  | 144hours |