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Completed

NCT Number: NCT02447367

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

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

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Key information

Conditions

LUTS Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JLP-1207(Fasted)

Drug

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

JLP-1207(Fed)

Drug

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

Primary outcomes

  1. AUClast, Cmax, AUCinf

    Time frame: 192 hours

Secondary outcomes

  1. Tmax

    Time frame: 192 hours

  2. t1/2

    Time frame: 192 hours

  3. CL/F

    Time frame: 192 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2015
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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