Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Treatments: Drug: Tamsulosin and solifenacin; Drug: Solifenacin; Drug: Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180997

JLP-1207-P1-DI

Details and patient eligibility

About

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

Full description

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Enrollment: 36 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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36 participants in 6 patient groups

Tamsulosin 1

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Solifenacin

Drug: Tamsulosin and solifenacin

Solifenacin 1

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Tamsulosin

Drug: Tamsulosin and solifenacin

Co-administration 1

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Solifenacin

Drug: Tamsulosin

Tamsulosin 2

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Solifenacin

Drug: Tamsulosin and solifenacin

Solifenacin 2

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Tamsulosin

Drug: Tamsulosin and solifenacin

Co-administration 2

Experimental group

Description:

Volunteers will be taken Tamsulosin and solifenacin

Treatment:

Drug: Solifenacin

Drug: Tamsulosin