A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

Study Overview
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Brief Summary
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This is a phase 1, open label, two-cohort, single-sequence, crossover study

Detailed Description
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This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

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

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Twynsta 80/5mg
* Drug: Crestor 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease 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 Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)

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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twynsta 80/5mg<br>Day 1   Day 9 : Twynsta 80/5mg / Day 10   Day 14 : Twynsta 80/5mg + Crestor 20mg | Drug: Twynsta 80/5mg<br>* Hypertension<br>* Other names: Telmisartan/Amlodipine 80/5mg;Drug: Crestor 20mg<br>* Hyperlipidemia<br>* Other names: Rosuvastatin 20mg;|
| Experimental: Crestor 20mg<br>Day 1   Day 5 : Crestor 20mg / Day 6   Day 14 : Twynsta 80/5mg + Crestor 20mg | Drug: Twynsta 80/5mg<br>* Hypertension<br>* Other names: Telmisartan/Amlodipine 80/5mg;Drug: Crestor 20mg<br>* Hyperlipidemia<br>* Other names: Rosuvastatin 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan, Amlodipine, Rosuvastatin AUCτ |  | 0 - 24 hr | 
| Telmisartan, Amlodipine, Rosuvastatin Cmax |  | 0 - 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan, Amlodipine, Rosuvastatin Tmax |  | 0 - 24 hr | 
| Telmisartan, Amlodipine, Rosuvastatin Cmin |  | 0 - 24 hr |