Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia; LUTS
• Intervention / Treatment: Drug: Solifenacin; Drug: Tamsulosin and solifenacin; Drug: Tamsulosin

Detailed Description

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-Gu
    • Seoul, Jongno-Gu, Korea, Republic of, 110-744
      • Seoul National University Hospital(SNUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 19~45 years healthy male
• Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2
• Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
• Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

• History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
• Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break
• An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
• Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
• History of drug abuse
• Positive urine drug screening
• Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
• Donated blood within 60 days prior to the first administration day in this study.

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin 1; Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin; Tamsulosin and solifenacin: Solifenacin 10 mg, once daily; Other Names: Vesicare tablet; Drug: Tamsulosin and solifenacin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily; Other Names: Harnal-D and Vesicare tablet
Experimental: Solifenacin 1; Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin and solifenacin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily; Other Names: Harnal-D and Vesicare tablet; Drug: Tamsulosin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily; Other Names: Harnal-D tablet
Experimental: Co-administration 1; Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin; Tamsulosin and solifenacin: Solifenacin 10 mg, once daily; Other Names: Vesicare tablet; Drug: Tamsulosin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily; Other Names: Harnal-D tablet
Experimental: Tamsulosin 2; Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin; Tamsulosin and solifenacin: Solifenacin 10 mg, once daily; Other Names: Vesicare tablet; Drug: Tamsulosin and solifenacin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily; Other Names: Harnal-D and Vesicare tablet
Experimental: Solifenacin 2; Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin and solifenacin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily; Other Names: Harnal-D and Vesicare tablet; Drug: Tamsulosin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily; Other Names: Harnal-D tablet
Experimental: Co-administration 2; Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin; Tamsulosin and solifenacin: Solifenacin 10 mg, once daily; Other Names: Vesicare tablet; Drug: Tamsulosin; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily; Other Names: Harnal-D tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCτ,ss, Cmax,ss	192h

Secondary Outcome Measures

Outcome Measure	Time Frame
C trough,ss	192h
Tmax,ss	192h
t1/2	192h
CL/F	192h

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kyung-sang Yu, M.D.,Ph.D., Seoul National University Hospital(SNUH)

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: α1-blockers; antimuscarinic agent
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Solifenacin Succinate
• Other Study ID Numbers: JLP-1207-P1-DI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No