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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Benign Prostatic Hyperplasia; LUTS(Lower Urinary Tract Symptoms); Overactive Bladder

Treatments: Drug: JLP-1207; Drug: Solifenacin 5mg+Tamsulosin 0.2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02494349

JLP-1207-P1-PK

Details and patient eligibility

About

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.

Full description

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

Enrollment: 54 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

JLP-1207

Experimental group

Description:

JLP-1207 dosing in the fed state(high fat meal)

Treatment:

Drug: JLP-1207

Solifenacin 5mg+Tamsulosin 0.2mg

Experimental group

Description:

Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)

Treatment:

Drug: Solifenacin 5mg+Tamsulosin 0.2mg