Randomized, open, and repeated dose clinical trials to evaluate the safety and pharmacokinetic properties of UIC201903 and UIC201904 when administered in healthy adult volunteers
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005234
- Lead Sponsor
- Korea United Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 48
1) Healty adult male aged 19 to 50 years dold at the time of screening
2) A person who weighs over 50kg and whose BMI is within the range of 18.0-29.0kg/m2
? BMI = (weight [kg])/(height [m])2
3) A person; who is judged to be suitable for testing through physical examination or examination conducted in accordance with this test plan. That is, a person who has no congenital or chronic disease, and has no medical history or findings within the last 3 years
4) A person; who has been determined to be suitable for testing as a result of clinical laboratory tests and ECG result, which are conducted in accordance with this test plan. (Even if the clinical laboratory test and ECG results are within the reference value of the Inha University School of Medicine or outside the scope, the investigator determines that it is clinically meaningless)
5) A person who has heard and fully understood the detailed description of this clinical trial and has agreed in writing to decide his participation voluntarily and to comply with the precautions.
1) A person who had or has the disease corresponding to clinically significant cardiovascular, respiratory system, liver, kidney, nervous system, endocrine system, blood tumor, mental illness, urinary system.
2) A person who had or has gastrointestinal diseases (such as gastrointestinal ulcers, gastritis, gastrointestinal cramps, gastrointestinal reflux disease, Crohn's disease, etc.) or who had or has a history of gastrointestinal surgery (except simple appendectomy or hermia surgery)
3) A person with genetic problems, such as fructose intolerance, glucose-galactos absorption disorder, or sucrose isomaltase deficiency.
4) A person who has a history of hypersensitivity of clinically significant hypersensitivity reactions to a drugs or other drug (such as aspirin, antibiotics, etc.) that contain(s) an ingredient of R-thioctic acid and Duloxetin or an ingredient of the same family.
5) A person who showed a clinically significant level of hypotension (systolic blood pressure < 90mmHg) or hypertension (systolic blood pressure = 150mmHg or diastolic blood pressure = 95mmHg) at the time of screening examination.
6) A person whose screening test result in any of the folllowing,
- AST or ALT > 2times of the upper limit of the normal range.
- Total bilirubin > 2.0mg/dL
- Glomerular filtration rate (eGFR) < 60mL/min/1.73m2
7) A person who drinks conrinuously (21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or cannot stop drinking during the clinical trial period.
8) A person who continues to smoke (more than 10 cigarettes/day) or is unable to stop smoking during the period of hospitalization of the clinical trial period.
9) A person who has participated in another clinical trial or bioequivalence test within six months before the date of the first dose or took medicine for clinical or bioequivalence testing within six months before the date of the first dose
10) A person who donated whole blood within 60 days before the first dose date, or who donated the ingredient within 30 days, or received blood transfusion within 30 days before the first dose date.
11) A person who took any prescription drug or herbal medicine within 14 days before the first dose date, or took any over The Counter Drug (OTC) within 7 days befor the 1st dose date. (but he may be participated in clinical trials if other conditions are reasonable according to the tester's judgment).
12) A person who took drug metabolizing enzyme-inducing and inhibitory drugs, such as barbital drugs, within one month before the start of the test.
13) A mental patient or a drug addict
14) A person who has eaten (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, or excretion of a drug within seven days before the first dose date.
15) A person who do not agree to exclude the possibility of pregnancy by using the medically recognized contraception* from the first date of clinical trial medication to the 7th day after the last date of clinical trial medication.
*Medical recognized contraception: Use a combination of intrauterine devices, vascular surgery, ovarian and blocking contraception (male condoms, female condoms, cervical caps, contraceptive diaphargm, sponge, etc.) or use a combination of two or more blocking contraceptives when using a spermicide.
16) A person who is unwilling or unable to comply with the dietary and lifestyle guidelines required for clinical testing.
17) A person whose other clinic
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt,ss, Cmax,ss of UIC201903 and UIC201904
- Secondary Outcome Measures
Name Time Method Cmin,ss, Tmax,ss, Vd/Fss,, CL/Fss,, t1/2 of UIC201903 and UIC201904