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The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

NCT02494349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

JLP-1207

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.

DRUG

Solifenacin 5mg+Tamsulosin 0.2mg

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.

Sponsors & Collaborators

  • Jeil Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-sang Yu, M.D., Ph.D. · Seoul National University Hospital(SNUH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-11-30
Completion
2015-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494349 on ClinicalTrials.gov