Status Approved
First Submitted Date
2018/07/02
Registered Date
2018/09/21
Last Updated Date
2018/07/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003213 |
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Unique Protocol ID | NVP-1402-01 |
Public/Brief Title | A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402 |
Scientific Title | A clinical trial to evaluate the pharmacokinetics ans safety of NVP-1402 compared with Exelon capsule in healthy male subjects |
Acronym | NVP-1402-01 |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT02897726 |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KNUH 2016-10-014-001 |
Approval Date | 2016-11-21 |
Institutional Review Board Name | Kyungpook national university hospital IRB |
Institutional Review Board Address | 130, Dongdeok-ro, Jung-gu, Daegu |
Institutional Review Board Telephone | 053-200-5430 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young Ran Yoon |
Title | Ph.D |
Telephone | +82-53-420-4950 |
Affiliation | Kyungpook National University |
Address | 130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea |
Contact Person for Public Queries | |
Name | Young Ran Yoon |
Title | Ph.D |
Telephone | +82-53-420-4950 |
Affiliation | Kyungpook National University |
Address | 130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea |
Contact Person for Updating Information | |
Name | Sol Ip Kang |
Title | CRM |
Telephone | +82-70-5118-2226 |
Affiliation | NVP Healthcare |
Address | 5, Jangan-ro 448beon-gil, Jangan-gu, Suwon-si, Gyeonggi-do, 16209, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2017-03-13 Actual | |
Target Number of Participant | 38 | |
Primary Completion Date | 2017-04-02 , Actual | |
Study Completion Date | 2017-07-03 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyungpook National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2017-03-13 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | NVP Healthcare |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | NVP Healthcare |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and exelon capsule in healthy male subjects. Randomized, open-label, single oral dose, active-controlled and crossover |
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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 | Arm1: Comparator Exelon capsule 3mg 1cap, BID / wash out 7days, Test drug NVP-1402 6mg 1Tablet, 1tab, once daily Arm2: Test drug NVP-1402 6mg 1Tablet, 1tab, once daily / wash out 7days, Comparator Exelon capsule 3mg 1cap, BID |
Number of Arms | 2 |
Arm 1 |
Arm Label Comparator |
Target Number of Participant 19 |
|
Arm Type Others |
|
Arm Description Exelon capsule 3mg 1capsule, BID (single oral dose), wash out 7days, Test drug NVP-1402 6mg 1Tablet, 1tab, once daily single oral dose) |
|
Arm 2 |
Arm Label Test drug |
Target Number of Participant 19 |
|
Arm Type Others |
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Arm Description Test drug NVP-1402 6mg 1Tablet, 1tab, once daily / wash out 7days, Comparator Exelon capsule 3mg 1cap, BID (single oral dose) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F03)Unspecified dementia |
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Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 19Year~No Limit |
|
Description 1)Healthy adult male volunteers aged 19years old at screening 2)Body weight 50 kg within the range of ± 20% of the calculated ideal body weight (IBW) IBW(kg) = {height (cm) – 100} x 0.9 3)Without any congenital or chronic diseases requiring treatment, any pathological symptoms, or any abnormal findings on medical examination 4)Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry, and urinalysis, etc. and electrocardiogram(ECG). 5)Subjects who signed on the written informed consent form and comply with study requirements after listening and fully understanding the details of this study. |
|
Exclusion Criteria |
1) Subjects with hypersensitivity to the active ingredients or other components of the investigational product(s) or medical history of significant hypersensitivity to other drugs or any additive(s). 2) Subjects with medical history to affect absorption, distribution, metabolism and elimination of drug(s) (disease(s) of hepatic/biliary, renal, cardiovascular, endocrine (hypothyroidism etc.), respiratory, digestive, hematologic, central nervous, psychiatric, musculoskeletal systems, etc.) 3) Subjects with active liver disease or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >1.5 times the upper limit of the normal range 4) Subjects with creatinine clearance <80 mL/min (Creatinine clearance calculated by Cockcroft-Gault’s formula using serum creatinine). 5) Subjects with gastrointestinal disease (Crohn's disease, active peptic ulcer disease, etc.) that would affect absorption of investigational products or history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) 6) Subjects with serious harms, surgical procedures or suspected symptoms of acute disease(s) (severe infection, severe injury, etc.) within 4 weeks prior to the first administration. 7) Subjects who continued excessive drinking alcohol (>21 units/week, 1unit=10g=12.5 mL of pure alcohol) or could not abstain from alcohol since 3 days before the day to conduct the study or excessive smokers (> 10 cigarettes /day). 8) History of Substance abuse 9) Ingesting any prescription drug(s) or herbal medicine(s) within 2 weeks prior to the first administration or any over-the-counter (OTC) drug(s) judged by the investigator to affect this study or the safety of the study subjects. 10) Subjects who participated in any other study within 3 months prior to the first administration (the end of the previous study is determined as the last day of administration). 11) Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration. 12) Subjects on abnormal diets which might affect absorption, distribution, metabolism and elimination of drug(s) or taking foods which might affect drug metabolism.(eg, grapefruit juice (1L or more per day) taken within 7 days prior to administration of the Investigational Product) 13) Someone who can't take a meal derived from this trial 14) Subjects with positive result of serologic test (HBsAg, HCV Ab, HIV Ab) 15) Subjects judged not eligible for this study by principal investigator or subinvestigator (physician in charge). |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Rivastigmine of Cmax, AUClast |
|
Timepoint | - Test drug: For each period pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12,14, 16, 24h / - Comparator: For each period, pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 24h |
|
Secondary Outcome(s) 1 | ||
Outcome | Rivastigmine of AUCinf, Tmax, t1/2 |
|
Timepoint | - Test drug: For each period pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12,14, 16, 24h / - Comparator: For each period, pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 24h |
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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