Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers

Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02447367

Enrollment

Registered

2015-05-18

Start date

2015-07-31

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, Overactive Bladder

Keywords

α1-blockers, antimuscarinic agent

Brief summary

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

Detailed description

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

Interventions

DRUGJLP-1207(Fasted)

Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.

DRUGJLP-1207(Fed)

Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed 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, AUCinf	192 hours

Secondary

Measure	Time frame
Tmax	192 hours
t1/2	192 hours
CL/F	192 hours

Outcome results

None listed

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