Status:
COMPLETED
Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Erectile Dysfunction
Benign Prostatic Hyperplasia
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02239484
Start Date
March 1 2014
End Date
September 1 2014
Last Update
September 12 2014
Active Locations (1)
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1
Samgsung Seoul Hospital
Seoul, South Korea