NCT02494349

Brief Summary

The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 24, 2016

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 8, 2015

Last Update Submit

June 23, 2016

Conditions

LUTS(Lower Urinary Tract Symptoms)Benign Prostatic HyperplasiaOveractive Bladder

Keywords

α1-blockersantimuscarinic agent

Outcome Measures

Primary Outcomes (1)

  • AUClast, Cmax

    192 hours

Secondary Outcomes (5)

  • AUCinf

    192 hours

  • Tmax

    192 hours

  • t1/2

    192 hours

  • CL/F

    192 hours

  • Vd/f

    192 hours

Study Arms (2)

JLP-1207

EXPERIMENTAL

JLP-1207 dosing in the fed state(high fat meal)

Drug: JLP-1207

Solifenacin 5mg+Tamsulosin 0.2mg

EXPERIMENTAL

Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)

Drug: Solifenacin 5mg+Tamsulosin 0.2mg

Interventions

JLP-1207DRUG

The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.

JLP-1207
Solifenacin 5mg+Tamsulosin 0.2mgDRUG

The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.

Solifenacin 5mg+Tamsulosin 0.2mg

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic HyperplasiaUrinary Bladder, Overactive

Interventions

Solifenacin SuccinateTamsulosin

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

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 8, 2015

First Posted

July 10, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

June 24, 2016

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share