Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02239484

Enrollment

Registered

2014-09-12

Start date

2014-03-31

Completion date

2014-09-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Erectile Dysfunction

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.

Interventions

DRUGTadalafil

DRUGTamsulosin

DRUGTadalafil + Tamsulosin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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 Cav	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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026