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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

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.