Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239484
• Other study ID #: HM-TASU-101
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2014
• Last updated: September 10, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Drug and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Erectile Dysfunction
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tadalafil

• Tamsulosin

• Tadalafil + Tamsulosin

Locations

Country	Name	City	State
Korea, Republic of	Samgsung Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tadalafil,Tamsulosin Cmax,ss		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Primary	Tadalafil,Tamsulosin AUCt		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin tmax,ss		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin t1/2		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin CL/Fss		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin Vd/Fss		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin Cav		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No
Secondary	Tadalafil,Tamsulosin Cmin,ss		6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)	No