KCT0000787
Active, not recruiting
未知
A randomized, open-label, multiple-dose, crossover phase ? study to compare the pharmacokinetic characteristics and safety of Dilatrend SR capsule 32 mg and Dilatrend® tablet 25 mg
Chong Kun Dang0 sites48 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Chong Kun Dang
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Between 20 aged and 35aged in healthy male
- •2\)Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
- •IBW(kg) \= {height(cm)\-100}\*0\.9
- •3\)Have not any congenital or chronic disease and medical symptoms.
- •4\)Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
- •5\)Agreement with written informed consent
Exclusion Criteria
- •\-Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.
- •\-Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.
- •\-Hypotension(SBP \< 105mmHg or DBP \< 65mmHg), Hypertension(SBP \> 150mmHg or DBP \> 100mmHg)
- •\-Heart rate \< 50times/minute
- •\-Active liver disease or AST, ALT \> 1\.5\*upper limit of normal range
- •\-Creatinine clearance \< 80mL/min
- •\-Subject has a disease affecting drug's ADME or gastrointestinal surgery.
- •\-Subject with symptoms of injured or acute disease within 28days before the first IP administration.
- •\-Subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine.
- •\-Taking ETC medicine including oriental medicine within 14days before the first IP administration or Taking OTC medicine within 7days
Outcomes
Primary Outcomes
Not specified
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