Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

Study Overview
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Brief Summary
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To evaluate Drug-drug interaction

Detailed Description
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The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Official Title
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An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Amlodipine
* Drug: Chlorthalidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight) Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease psychiatric, or malignancy. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. Administration of other investigational products within 3 months prior to the first dosing. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study). Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Part B<br>Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan. | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Chlorthalidone<br> <br> |
| Other: Part A<br>Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone. | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Chlorthalidone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone |  | Totally 28points for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone |  | Totally 28points for 24 hours |