The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Study Overview
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Brief Summary
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To investigate the pharmacokinetic Drug-drug interaction

Detailed Description
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The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Official Title
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A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Conditions
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Healthy Male Volunteer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 19 to 50 Participant who has a body weight that is >=55kg(male) and body mass index (BMI) level that is 18 30 Provision of signed written informed consent Exclusion Criteria: History of clinically significant disease History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine 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 2 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 the reasons including laboratory test results, ECGs, or vital signs.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telmisartan, Amlodipine, Rosuvastatin<br>This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |
| Experimental: Telmisartan, Amlodipine, Rosuvastatin<br>This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers | Drug: Telmisartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine |  | 0h 24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine |  | 0h 24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of peak concentration in steady state of Telmisartan and Amlodipine |  | 0h 24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine |  | 0h 24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) | 
| Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin |  | 0h 24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0 24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin) |