A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003213
- Lead Sponsor
- avipharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 38
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.
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).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rivastigmine of Cmax, AUClast
- Secondary Outcome Measures
Name Time Method Rivastigmine of AUCinf, Tmax, t1/2