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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180997
• Other study ID #: JLP-1207-P1-DI
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2014
• Last updated: June 23, 2016
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2014
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• LUTS
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Tamsulosin
Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily
• Solifenacin
Tamsulosin and solifenacin: Solifenacin 10 mg, once daily
• Tamsulosin and solifenacin
Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital(SNUH)	Seoul	Jongno-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt,ss, Cmax,ss		192h	No
Secondary	C trough,ss		192h	No
Secondary	Tmax,ss		192h	No
Secondary	t1/2		192h	No
Secondary	CL/F		192h	No