Back to resultsEvaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
Primary Purpose
Erectile Dysfunction, Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tadalafil
Tamsulosin
Tadalafil + Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Samgsung Seoul Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Arm Description
Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
Outcomes
Primary Outcome Measures
Tadalafil,Tamsulosin Cmax,ss
Tadalafil,Tamsulosin AUCτ
Secondary Outcome Measures
Tadalafil,Tamsulosin tmax,ss
Tadalafil,Tamsulosin t1/2
Tadalafil,Tamsulosin CL/Fss
Tadalafil,Tamsulosin Vd/Fss
Tadalafil,Tamsulosin Cav
Tadalafil,Tamsulosin Cmin,ss
Full Information
NCT ID
NCT02239484
First Posted
September 4, 2014
Last Updated
September 10, 2014
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02239484
Brief Title
Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
Official Title
An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 period repeatedly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Type
Drug
Intervention Name(s)
Tadalafil + Tamsulosin
Primary Outcome Measure Information:
Title
Tadalafil,Tamsulosin Cmax,ss
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin AUCτ
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Secondary Outcome Measure Information:
Title
Tadalafil,Tamsulosin tmax,ss
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin t1/2
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin CL/Fss
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin Vd/Fss
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin Cav
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Title
Tadalafil,Tamsulosin Cmin,ss
Time Frame
6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Samgsung Seoul Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
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