Status:
UNKNOWN
A Clinical Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A clinical study to compare the safety and pharmacokinetics of CKD-320 and D012
Detailed Description
A randomized, open-label, single-dose, replicate-crossover study to compare the safety and pharmacokinetics of CKD-320 and D012 in healthy subjects
Eligibility Criteria
Inclusion
- Healthy adult older than 19 years at the time of screening
- Body weight more than 55kg and within ±20% of the calculated ideal body weight(IBW = (height -100) x 0.9)
- No congenital or chronic disease and no pathological symptoms or findings
- Suitable subject who is determined to be suitable in laboratory testing such as hematology, blood chemistry, urinalysis and 12-lead electrocardiogram
- Subject who have received a detailed explanation of this clinical trial and have fully understood it, and agree in writing to comply
Exclusion
- Subject who has a history of clinical significant hepatobiliary, kidney, digestive, respiratory, blood-oncology, endocrine, urinary, psychiatric, musculoskeletal, immune, acute and unstable heart failure or evidence
- Subject with a history of gastrointestinal disorders(Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery) that may affect the absorption
- A hereditary angioedema patient, with a history angioedema, or hereditary fructose patient
- Clinical laboratory test results showing the following values
- ALT or AST \> 2 times upper limit of normal range
- eGFR \< 60mL/min/1.73m2
- Subject with a history of overreaction or clinical significant hypersensitivity to drugs
- Subject who has a systolic blood pressure \> 140mmHg or \< 100mmHg, diastolic blood pressure \> 90mmHg or \< 60mmHg, pulses ≥ 100 per minutes
- In case of past history of drug abuse or positive for urine test of drug abuse
- Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
- Those taking prescription drugs, natural drug(ex, St. John's wort), herbal medicine within 14days and non-prescription drugs or vitamin supplements within 7days before the first administration of clinical trial drug
- Those taking other clinical trial drugs or bioequivalence test drugs within 6months before the first administration of clinical trial drug
- Those who donated whole blood within 2 months or those who donated the components within 1 month or blood transfusion within 1 month before the first administration of the clinical trial drug
- Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)
- \> 10 smokers per day within 3months of screening and those who can't quit smoking
- Blood test(RPR Ab, HBS Ag, HCV Ab, anti HIV(AIDS)) results indicate a positive
- Subject who can't comply with the lifestyle guidelines
- A pregnant(a likely), breastfeeding women
- Subject who don't agree or can't comply reliable contraception from screening to 14days after the last drug administration
- Subject who is judged by the investigator principal to be ineligible to participate in the clinical trial
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04035538
Start Date
August 1 2019
End Date
December 1 2019
Last Update
July 29 2019
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