KCT0004396
Completed
未知
The phase 1 study to evaluate the pharmacokinetic drug-drug interaction and safety between EL-1804R-1 and EL-1804R-2 in healthy male volunteers
Elyson Pharmaceutical0 sites40 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Elyson Pharmaceutical
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy male subject’s age 19\~50 years at screening
- •2\) BMI 18\.0\-29\.0kg/m2 and weight more than 50kg
- •3\) Subject who don't have congenital or chronic diseases and have no abnormal medical examination results
- •4\) Suitable subject who is determined by ECG and laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug at screening
- •5\) Subjects who fully understand the clinical trials after in\-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by INHA University Hospital IRB
- •6\) Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures
Exclusion Criteria
- •1\) Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •2\) Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- •3\) Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose\-galactose malabsorption
- •4\) SUbjects with a history of hypersensitivity or clinically significant hypersensitivity to drugs or other drugs containing the active ingredients or components of the IP
- •5\) Subjects who show hypotension (Systolic Blood Pressure \< 90mmHg), hypertension (SBP \=150mmHg) or Diastolic Blood Pressure \= 95 mmHg at screening
- •6\) Subjects with the following results;
- •\- AST or ALT \> 2 times upper limit of normal range
- •\- Total billuribin \> 2\.0mg/mL
- •\- eGFR \< 60 mL/min/1\.73m2
- •7\) Subjects who drink continuosly (more than 21 units/week, 1 unit \= 10g \= 12\.5mL of pure alcohol) or who can\`t drink during the study period
Outcomes
Primary Outcomes
Not specified
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