Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

Study Overview
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Brief Summary
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We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both together in a 3 period repeatedly.

Official Title
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An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers

Conditions
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Erectile Dysfunction, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tadalafil
* Drug: Tamsulosin
* Drug: Tadalafil + Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, age 20 to 55 years. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range. Systolic blood pressure <90mmHg or Diastolic blood pressure < 70 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Sequence 1<br>Tadalafil→Tamsulosin→Tadalafil+Tamsulosin | Drug: Tadalafil<br> <br> Drug: Tamsulosin<br> <br> Drug: Tadalafil + Tamsulosin<br> <br> |
| Experimental: Sequence 2<br>Tadalafil+Tamsulosin→Tadalafil→Tamsulosin | Drug: Tadalafil<br> <br> Drug: Tamsulosin<br> <br> Drug: Tadalafil + Tamsulosin<br> <br> |
| Experimental: Sequence 3<br>Tamsulosin→Tadalafil+Tamsulosin→Tadalafil | Drug: Tadalafil<br> <br> Drug: Tamsulosin<br> <br> Drug: Tadalafil + Tamsulosin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tadalafil,Tamsulosin Cmax,ss |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin AUCτ |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tadalafil,Tamsulosin tmax,ss |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin t1/2 |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin CL/Fss |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin Vd/Fss |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin Cav |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) | 
| Tadalafil,Tamsulosin Cmin,ss |  | 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14) |