The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers

Study Overview
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Brief Summary
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The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.

Official Title
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An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers

Conditions
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Hypertension With Dyslipidemia

Intervention / Treatment
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* Drug: JLP-1401
* Drug: Telmisartan/Amlodipine, Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2 Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial Subject who has the ability and willingness to participate the whole period of trial Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Subjects who are allergic to investigational drug. Subjects who have a medical history which can affect the clinical trial. SBP < 90 mmHG, SBP > 140mmHG or DBP < 60 mmHG, DBP > 100mmHg AST or ALT > X 2 UNL CK > X 2 UNL History of drug abuse or positive drug screening. Participation in other drug studies within 3 months prior to the drug administration. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

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

Sexes Eligible for Study
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All

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 I (JLP-1401)<br>JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg) | Drug: JLP-1401<br>* Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)<br>Drug: Telmisartan/Amlodipine, Rosuvastatin<br>* Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)<br>|
| Active Comparator: Group II (Telmisartan/Amlodipine, Rosuvastatin)<br>Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg) | Drug: JLP-1401<br>* Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)<br>Drug: Telmisartan/Amlodipine, Rosuvastatin<br>* Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline | 72 hr after baseline | 
| Cmax | Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline | 72 hr after baseline |