Pharmacokinetics and safety of DA-6034
- Conditions
- Not Applicable
- Registration Number
- KCT0000793
- Lead Sponsor
- Dong-A Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 67
(1) Healthy male adult subjects aged 19 to 45 years who are considered to be suitable to participate in the study based on prior examination within 3 weeks before the study commencement
(2) Subjects with body weight of >45kg, and a within ±15% of ideal body weight
ideal body weight = (Height(cm)-100)*0.9
(3) Subjects who voluntarily decided to partipate and gave written consent.
(4) Subjects who are reliable, cooperative, obligible to limitations during the study
(1) Subjects with a previous history or present abnormal symtoms of cardiology, respiratory, renal, hepatic, gastrointestinal, and neurologic diseases (especially myocardial infarction, stroke, hypotension (SBP/DBP < 90/50mmHg), uncontrolled hypertension(SBP/DBP > 150/95mmHg), coronary arterial diseases)
(2) Subjects with a previous history of clinically significant allergies (e.g. asthma)
(3) Subjects with hematological disorders
(4) Subjects with febrile disease or infectious diseases within 2 weeks before the study commencement
(5) Subjects who made whole blood donation within 2 months before the study commencement or blood component donation within 1 month before the study commencement
(6) Subjects who have participated in another clinical study within 30 days before the commencement of study
(7) Subjects with clinically significant neuropsychiatric disorders
(8) Subjects with a previous history of drug abuse
(9)Subjects with a previous history of drug allergies or other hypersensitivity reactions
(10) Subjects who are positive for HBs antigen, HCV antibody, or HiV antibody at prior examination
(11) Subjects who have continuous alcohol ingestion (>28 units/week) or do not agree to stop drinking during the study
(12) Smokers (except subjects who quit smoking before 3 months before the study commencement)
(13) Subjects who regularly administer over the counter medicine except prescribed medicine or vitamin/minerals
(14) Subjects who have used any drugs within 7 days before the study commencement
(15) Subjects who are permanently accommodated in a public institution
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety, tolerability
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of DA-6034