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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Erectile Dysfunction
• Intervention / Treatment: Drug: Tamsulosin; Drug: Tadalafil; Drug: Tadalafil + Tamsulosin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samgsung Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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 t1/2	6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
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 Cav	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)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Prostatic Hyperplasia; Hyperplasia; Erectile Dysfunction; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin
• Other Study ID Numbers: HM-TASU-101