KCT0004252
Completed
未知
A phase I clinical trial to investigate the food effect on the pharmacokinetics of NVP-1402 in healthy volunteers
avipharm0 sites32 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- avipharm
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Healthy adult male volunteers aged 19years old at screening
- •2\)Body weight ? 50 kg within the range of 18\.5\~27\.0 kg/m2 of the calculated BMI
- •?BMI \= {weight(kg)/height(m)2
- •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\) Those who showed signs of systolic blood pressure\> 150 mmHg or \<90 mmHg, or diastolic blood pressure\> 100 mmHg or \<60 mmHg in vital signs measured at rest after 3 minutes or more resting
- •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\) 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) within 1 week, judged by the investigator to affect this study or the safety of the study subjects.
- •9\) History of Substance abuse
- •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).
Outcomes
Primary Outcomes
Not specified
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