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

Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02494349

Enrollment

Registered

2015-07-10

Start date

2015-08-31

Completion date

2015-12-31

Last updated

2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, LUTS(Lower Urinary Tract Symptoms), Overactive Bladder

Keywords

α1-blockers, antimuscarinic agent

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.

Detailed description

A randomized, open-label, single dose, two-way crossover study.

Interventions

DRUGJLP-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.

DRUGSolifenacin 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUClast, Cmax	192 hours

Secondary

Measure	Time frame
Vd/f	192 hours
AUCinf	192 hours
Tmax	192 hours
t1/2	192 hours
CL/F	192 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026