A Randomized, Open-label, Single-dose, Four-sequence, Four -period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001363
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
1. 20~45 years old, Healthy Adult Male Subject
2. Body Weight = 50kg and Ideal Body Weight = ±20%
3. Do not have any disease or symptoms which is clinically significant
4. Acceptable physical examination and clinical examination, during screening
5. Provision of signed written informed consent confirmed IRB
1. A subject with a history of tamslosin hypersensitivity reaction or clinically significant hypersensitivity reaction
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
3. A subject with a history of gastrointestinal disease(crohn's disease, Ulcer) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
4. Unacceptable physical examination and clinical examination, during screening within 28 days prior to the participation in clinical trials
5. someone who has a result
- ALT or AST > 1.25 times (Upper Normal Range)
- Total Bilirubin > 1.5 times (Upper Normal Range)
6. Systolic BP >160 mmHg or < 80 mmHg, Diastolic BP >100 mmHg or < 50 mmHg
7. someone who has a history of drug abuse or misuse
- alcohol abuse is consumption exceeding 21 units/week
8. someone who hsa taken a Investigator Product from other trial within 3 months before Investigator Product first medication
9. Investigator Product first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 1 month
10. someone who has taken other Ethical drugs or herbal medicine within 2 weeks, over the counter drugs or vitamins medicine within 1 week
11. someone who has taken abnormal meals like which can affect to Absorption, Distribution, Metabolism , Excretion
12. Blood donation during 2 months or apheresis during 1 month before the study
13. galactose intolerance, Lapp lactose deficiency someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
14. Use of tobacco in excess of the equivalent of 10 cigarettes per day
15. someone who has taken positive result of HBsAg, HCV Ab, HIV Ab
16. Judged to be inappropriate for the study by the investigator after reviewing other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® Cmax, AUClast
- Secondary Outcome Measures
Name Time Method Tmax of Tamsulosin; t1/2 of Tamsulosin;Vz/F of Tamsulosin;CL/F of Tamsulosin