Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Official Title
-----------------
An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Conditions
-----------------
Hypertension With Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: telmisartan/amlodipine and atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 55 years healthy male The result of Body Mass Index(BMI) is not less than 19 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 ≤ 70mmHg) Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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<br>Period I: administration of telmisartan/Amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days Period II: atorvastatin for 4 days | Drug: telmisartan/amlodipine and atorvastatin<br>* Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days<br>|
| Experimental: Group II<br>Period I: administration of atorvastatin for 4 days Period II: administration of telmisartan/amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days | Drug: telmisartan/amlodipine and atorvastatin<br>* Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin |  | Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours | 
| Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin |  | Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours |