Study to Compare the Safety and Pharmacokinetics of CKD-397

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.

Detailed Description
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A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Official Title
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A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 in Healthy Male Subjects

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: CKD-397
* Drug: TD+TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 19 years in Healthy male volunteer Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2 Subject who signed on an informed consent form willingly Exclusion Criteria: Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy) Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy) Aspartate aminotransferase, Alanine aminotransferase > 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) < 60mL/min/1.73m2 Continuously taking excessive alcohol(>210g/week) within 6 months before screening Have received any other investigational drug within 3 months prior to the first dosing Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg Subject with orthostatic hypotension The history of drug abuse or drug abuse showed a positive for urine drug test Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results. Subject with taking any forms of organic nitrate periodically and/or intermittently. Subject with known hereditary degenerative retinal disease including retinitis pigmentosa. Subject with serious history of hypersensitivity to investigational product (including Tadalafil and Tamsulosin) and other medicine (aspirin, antibiotics and so on) Subject who lost sight of one eye by non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy). Subject with genetic problems such as galactose intolerance, fructose intolerance, lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency Subject who planned pregnancy during clinical trial and doesn't use trustworthy contraception Subjects who is not able to comply with guidelines described in the protocol. An impossible one who participants in clinical trials by investigator's decision including laboratory test result or another reason

Ages Eligible for Study
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Minimum Age: 19 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CKD-397<br>Tadalafil/ Tamsulosin Fixed dose combination | Drug: CKD-397<br>* Arm A:Tamsulosin/ Tadalafil Fixed dose combination<br>* Other names: Arm A;|
| Experimental: TD+TM<br>Tadalafil/ Tamsulosin Coadministration | Drug: TD+TM<br>* Arm B: Tamsulosin/ Tadalafil Coadministration<br>* Other names: Arm B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| AUCinf of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| Tmax of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| t1/2 of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| CL/F of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| Vd/F of Tadalafil/ Tamsulosin |  | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, Healthy Male Volunteer, Tamsulosin, Tadalafil