Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers

Overactive Bladder Clinical Trial

Official title:

Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447367
• Other study ID #: JLP-1207-P1-FE
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2015
• Last updated: June 23, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: June 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 the pharmacokinetic drug interaction 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: September 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:
• JLP-1207(Fasted)
Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.
• JLP-1207(Fed)
Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed 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, AUCinf		192 hours	No
Secondary	Tmax		192 hours	No
Secondary	t1/2		192 hours	No
Secondary	CL/F		192 hours	No