A randomized, open-label, and single-dose study to evaluate the safety and the pharmacokinetics after concurrent administration of UIC202007 and UIC202008 in healthy adult subjects
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0005901
- Lead Sponsor
- Korea United Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
1) A healthy adult male between 19 and 55 years of age at the time of screening test
2) A person who weighs more than 50 kg and whose calculated BMI is within the range of 18.0-29.0 kg/m2.
? BMI = (weight [kg])/(height [m])2
3) A person who is judged to be eligible for the test through physical examination and history taking according to this test plan. That is a person who has no congenital or chronic disease and has no pathological symptoms or findings as a result of internal examination within the past three years.
4) A person who is judged to be suitable for clinical laboratory examination and ECG results conducted according to this test plan (if the tester determines that the clinical laboratory examination and ECG results are not clinically meaningful even if they are within or beyond the reference value of Inha University Medical School)
5) A person who has heard and fully understood this clinical trial, agreed to comply with the precautions, and has decided to participate voluntarily in written consent.
1) A person who has or has a history of clinically significant cardiovascular, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, mental illness, or urinary system
2) A person who has or has a history of gastrointestinal diseases which may affect the absorption of medications for clinical trials (gastrointestinal ulcer, gastritis, stomach cramps, gastrointestinal reflux disease, Crohn's disease, etc.) or who has a history of gastrointestinal surgery (except simple appendectomy or hernia surgery)
3) A person who has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4) A person who has a history of hypersensitivity or clinically significant hypersensitivity to montelukast, bepotastine, drugs containing the same family of montelukast or bepotastine, or other medications (aspirins, antibiotics, etc.)
5) A person who showed a clinically significant low blood pressure (systolic blood pressure < 90mmHg) or high blood pressure (systolic blood pressure = 150mmHg or diastolic blood pressure = 95mmHg) during the screening test
6) A person whose screening tests show any of the following results:
- AST or ALT > Double the upper limit of the normal range
- Total bilirubin > 2.0 mg/dL
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
7) A person who continuously drinks alcohol (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or is unable to stop drinking alcohol during clinical trials
8) A person who continuously smokes (more than 10 cigarettes/day) or is unable to quit smoking during the period of admission of this clinical trial
9) A person who participated in other clinical trials or biological equivalence tests within six months (the last day of taking medication for clinical or biological equivalence tests) prior to the date of first administration
10) A person who has donated whole blood within 60 days before the first injection date, or who has donated blood within 30 days, or who has received blood transfusion within 30 days
11) A person who has taken any prescription medication or herbal medicine within 14 days prior to the first day of administration or who has taken any general medication (OTC) within 7 days (However, they may participate in clinical trials if other conditions are reasonable according to the tester's judgment)
12) A person who has taken medication that can induce or inhibit drug metabolism such as barbital drugs, within one month prior to the date of first administration
13) A person who has had a diet (especially grapefruit juice or its products) within seven days prior to the date of first administration that may affect the absorption, distribution, metabolism, or excretion of the drugs
14) A person who has not agreed to exclude the possibility of pregnancy by using medically recognized contraception* from the first day of administration to the 7th day after the last day of administration.
* Medically recognized contraception: Using combination of intrauterine devices, vasectomy, tubal ligation, and barrier contraception method (condoms for male, condoms for female, pessary, contraceptive diaphragm, sponges, etc.) or using more than two kinds of barrier contraception method when using a salivary agent
15) A person with mental illness and drug addiction
16) A person who is not willing or unable to comply with the dietary and lifestyle guidelines required for clinical trials
17) A pe
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of UIC202007 and UIC202008;Adverse drug reaction, physical examination, vital signs, ECG, clinical laboratory examination
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax , t1/2, Vd/F, CL/F of UIC202007 and UIC202008