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

Overactive Bladder Clinical Trial

Official title:

Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494349
• Other study ID #: JLP-1207-P1-PK
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2015
• Last updated: June 23, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: November 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
• Lower Urinary Tract Symptoms
• LUTS(Lower Urinary Tract Symptoms)
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• JLP-1207
The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
• Solifenacin 5mg+Tamsulosin 0.2mg
The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast, Cmax		192 hours	No
Secondary	AUCinf		192 hours	No
Secondary	Tmax		192 hours	No
Secondary	t1/2		192 hours	No
Secondary	CL/F		192 hours	No
Secondary	Vd/f		192 hours	No