Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

Phase 1

Completed

• Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia
• Interventions: Drug: Tadalafil; Drug: Tamsulosin; Drug: Tadalafil + Tamsulosin

• Registration Number: NCT02239484
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 3	Tamsulosin	Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
Sequence 1	Tadalafil	Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
Sequence 1	Tamsulosin	Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
Sequence 1	Tadalafil + Tamsulosin	Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
Sequence 2	Tadalafil	Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
Sequence 2	Tadalafil + Tamsulosin	Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
Sequence 2	Tamsulosin	Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
Sequence 3	Tadalafil	Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
Sequence 3	Tadalafil + Tamsulosin	Tamsulosin→Tadalafil+Tamsulosin→Tadalafil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 tmax,ss	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)
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 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)

Trial Locations

Locations (1)

Samgsung Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of