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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02447367
Other study ID # JLP-1207-P1-FE
Secondary ID
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


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
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