Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02239484
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 6
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction; Benign Prostatic Hyperplasia	Drug: Tadalafil; Drug: Tamsulosin; Drug: Tadalafil + Tamsulosin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Tadalafil→Tamsulosin→Tadalafil+Tamsulosin	Drug: Tadalafil; Drug: Tamsulosin; Drug: Tadalafil + Tamsulosin
Experimental: Sequence 2 Tadalafil+Tamsulosin→Tadalafil→Tamsulosin	Drug: Tadalafil; Drug: Tamsulosin; Drug: Tadalafil + Tamsulosin
Experimental: Sequence 3 Tamsulosin→Tadalafil+Tamsulosin→Tadalafil	Drug: Tadalafil; Drug: Tamsulosin; Drug: Tadalafil + Tamsulosin

Outcome Measures

Primary Outcome Measures

1. Tadalafil,Tamsulosin Cmax,ss [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

2. 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

1. Tadalafil,Tamsulosin tmax,ss [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

2. Tadalafil,Tamsulosin t1/2 [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

3. Tadalafil,Tamsulosin CL/Fss [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

4. Tadalafil,Tamsulosin Vd/Fss [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

5. Tadalafil,Tamsulosin Cav [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

6. Tadalafil,Tamsulosin Cmin,ss [6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy male volunteers, age 20 to 55 years.

2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2

3. 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:

1. 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.

2. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.

3. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samgsung Seoul Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT02239484
• Other Study ID Numbers: HM-TASU-101
• First Posted: Sep 12, 2014
• Last Update Posted: Sep 12, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hyperplasia; Tadalafil; Tamsulosin

Study Results

No Results Posted as of Sep 12, 2014