Status Approved
First Submitted Date
2021/01/27
Registered Date
2021/02/17
Last Updated Date
2021/01/27
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005901 |
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Unique Protocol ID | KUP-UI064-101 |
Public/Brief Title | 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 |
Scientific Title | 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 |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-11-010 |
Approval Date | 2021-01-04 |
Institutional Review Board Name | Inha University Hospital, Institutional Review Board |
Institutional Review Board Address | 27, Inhang-ro, Jung-gu, Incheon |
Institutional Review Board Telephone | 032-890-3691 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Sang Heon Cho |
Title | Associate professor |
Telephone | +82-32-890-1122 |
Affiliation | Inha University Hospital |
Address | 27, Inhang-ro, Jung-gu, Incheon |
Contact Person for Public Queries | |
Name | Sang Heon Cho |
Title | Associate professor |
Telephone | +82-32-890-1122 |
Affiliation | Inha University Hospital |
Address | 27, Inhang-ro, Jung-gu, Incheon |
Contact Person for Updating Information | |
Name | Yerin Kim |
Title | Associate |
Telephone | +82-2-558-8612 |
Affiliation | Korea United Pharm |
Address | 41, 102-gil, Kangnam-daero, Kangnam-gu, Seoul, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-25 Anticipated | |
Target Number of Participant | 30 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inha University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-25 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea United Pharm |
Organization Type | Pharmaceutical Company |
Project ID | KUP-UI064-101 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea United Pharm |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | Evaluate the safety and the pharmacokinetics after concurrent administration of UIC202007 and UIC202008 in healthy adult subjects |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1 |
Intervention Model | Cross-over |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | 1. Arm A: administration of 1 tablet of UIC202007, once 2. Arm B: administration of 1 tablet of UIC202008, once 3. Arm C: concurrent administration of 1 tablet of UIC202007 and UIC202008, once |
Number of Arms | 3 |
Arm 1 |
Arm Label A |
Target Number of Participant 10 |
|
Arm Type Experimental |
|
Arm Description administration of 1 tablet of UIC202007, once |
|
Arm 2 |
Arm Label B |
Target Number of Participant 10 |
|
Arm Type Experimental |
|
Arm Description administration of 1 tablet of UIC202008, once |
|
Arm 3 |
Arm Label C |
Target Number of Participant 10 |
|
Arm Type Experimental |
|
Arm Description concurrent administration of 1 tablet of UIC202007 and UIC202008, once |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J98.9)Respiratory disorder, unspecified Respiratory System |
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Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 19Year~55Year |
|
Description 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. |
|
Exclusion Criteria |
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 person whose any other clinical laboratory test results indicate clinically significant abnormalities or who has been determined as unsuitable participants for other reasons(e.g., non-compliance with instructions, uncooperative attitudes, etc.) by tester. |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Pharmacokinetics | |
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Primary Outcome(s) 1 | ||
Outcome | AUCt, Cmax of UIC202007 and UIC202008 |
|
Timepoint | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24hr |
|
Primary Outcome(s) 2 | ||
Outcome | Adverse drug reaction, physical examination, vital signs, ECG, clinical laboratory examination |
|
Timepoint | During the clinical trial |
|
Secondary Outcome(s) 1 | ||
Outcome | AUCinf, Tmax , t1/2, Vd/F, CL/F of UIC202007 and UIC202008 |
|
Timepoint | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24hr |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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