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

NCT02180997 | Completed Phase 1

• 1 other identifier: JLP-1207-P1-DI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Keywords

α1-blockers; antimuscarinic agent

Outcome Measures

Primary Outcomes (1)

• AUCτ,ss, Cmax,ss

  192h

Secondary Outcomes (4)

• C trough,ss

  192h

• Tmax,ss

  192h

• t1/2

  192h

• CL/F

  192h

Study Arms (6)

Tamsulosin 1

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Solifenacin; Drug: Tamsulosin and solifenacin

Solifenacin 1

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Tamsulosin; Drug: Tamsulosin and solifenacin

Co-administration 1

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Tamsulosin; Drug: Solifenacin

Tamsulosin 2

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Solifenacin; Drug: Tamsulosin and solifenacin

Solifenacin 2

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Tamsulosin; Drug: Tamsulosin and solifenacin

Co-administration 2

EXPERIMENTAL

Volunteers will be taken Tamsulosin and solifenacin

Drug: Tamsulosin; Drug: Solifenacin

Interventions

Tamsulosin DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Also known as: Harnal-D tablet

Co-administration 1; Co-administration 2; Solifenacin 1; Solifenacin 2

Solifenacin DRUG

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Also known as: Vesicare tablet

Co-administration 1; Co-administration 2; Tamsulosin 1; Tamsulosin 2

Tamsulosin and solifenacin DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Also known as: Harnal-D and Vesicare tablet

Solifenacin 1; Solifenacin 2; Tamsulosin 1; Tamsulosin 2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital(SNUH)

Seoul, Jongno-Gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder, Overactive

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kyung-sang Yu, M.D.,Ph.D.

  Seoul National University Hospital(SNUH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 3, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 24, 2016

Record last verified: 2014-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)