KCT0004878
Not yet recruiting
未知
A Clinical Trial for Evaluation of Pharmacokinetic interaction between WS1313D and NAC after Co-administration in Healthy Male Adult Subjects
Woosung Pharma0 sites27 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Woosung Pharma
- Enrollment
- 27
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects enrolled in this study must meet all of the following selection criteria:
- •1\)Healthy adult males between 19 and 45 years old at the time of screening
- •2\)A person who weighs more than 50kg and has a weight within ± 20% of the ideal body weight
- •3\) A person who voluntarily decides to participate in a clinical trial and agrees to follow precautions after hearing a detailed description of the trial
Exclusion Criteria
- •Subjects enrolled in this study are excluded if any of the following exclusion criteria apply.
- •1\)Person who is unable to collect blood up to 7ml / kg per day as required by this study
- •2\) Drugs containing acetaminophen (paracetamol) or propacetamol within 24 hours prior to clinical trial drug administration and within 12 hours prior to screening, or drugs containing probenecid, isoniazide within 48 hours And if you received medication containing disulfiram within a month
- •3\) Patients with severe hepatic impairment or total bilirubin measured more than 1\.5 times the normal upper limit of the clinical laboratory or whose ALT or AST is 2\.5 times higher than the normal upper limit
- •4\) Patients with severe renal impairment or those with an estimated glomerular filtration rate (eGFR) of 1/3 or less of the normal lower limit of the clinical laboratory
- •5\) Patients with symptoms suspected of acute disease 28 days before the start of trial (clinical administration)
- •6\) Patient Who has History that can affect the absorption, distribution, metabolism, and excretion of drugs(Cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignant tumor.)
- •7\) Applicants deemed unsuitable as subjects through Health examination conducted within 28 days of start of trial (Screening items such as paperweight, blood pressure, 12\-lead ECG, physical examination, blood, urine test)
- •8\) Patients with Bilateral renal artery stenosis, renal artery stenosis in a single kidney, or only one side of the kidneys functioning, such as those who show abnormalities in renal function in the past
- •9\) Patients with Clinically significant allergic disease(Excluding mild allergic rhinitis that does not require medication)
Outcomes
Primary Outcomes
Not specified
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