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
| Registry | NCT02447367 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 54 (Actual) |
| Sponsor | Jeil Pharmaceutical Co., Ltd. (Industry) |
| Conditions | LUTS, Benign Prostatic Hyperplasia, Overactive Bladder |
| Interventions | JLP-1207(Fasted), JLP-1207(Fed) (Drug) |
| Dates | start 2015-07-01, primary completion 2015-09-01, completion 2015-12-01, first posted 2015-05-18, last updated 2016-06-24 |
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All trials for LUTS All trials for Benign Prostatic Hyperplasia All trials of JLP-1207(Fasted) All trials of JLP-1207(Fed)
The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
A randomized, open-label, single dose, two-way crossover study
| Arm | Type | Interventions | Description |
|---|---|---|---|
| JLP-1207, Fasted followed by fed | Experimental | Drug: JLP-1207(Fasted) | JLP-1207 dosing in the fasted state followed by fed dosing |
| JLP-1207, Fed followed by fasted | Experimental | Drug: JLP-1207(Fed) | JLP-1207 dosing in the fed state followed by fasted dosing |
Sex: Male, ages: 19 Years to 45 Years, accepts healthy volunteers
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.