Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions
- Conditions
- Cardiovascular Diseases
- Interventions
- Drug: Reference drugDrug: Test drug 1Drug: Test drug 2
- Registration Number
- NCT04678388
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions
- Detailed Description
A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
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Healthy adult aged more than 19 at the time of screening
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Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²
BMI=Weight(kg) / Height(m)²
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Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
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Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
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Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
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Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.
- Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
- Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
- Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
- Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
- Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
- Those who have taken any drugs that may affect the clinical trial within 10 days.
- Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
- Those who are deemed insufficient to participate in this clinical study by investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2 Test drug 1 1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Group 2 Test drug 2 1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Group 1 Test drug 1 1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 Group 1 Test drug 2 1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 Group 4 Test drug 1 1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Group 5 Test drug 2 1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 Group 3 Test drug 1 1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug Group 6 Reference drug 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 Group 6 Test drug 2 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 Group 1 Reference drug 1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 Group 5 Reference drug 1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 Group 6 Test drug 1 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 Group 2 Reference drug 1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Group 3 Reference drug 1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug Group 3 Test drug 2 1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug Group 4 Reference drug 1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Group 4 Test drug 2 1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Group 5 Test drug 1 1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2
- Primary Outcome Measures
Name Time Method AUCt of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Area under the concentration-time curve from time zero to time of CKD-385
Cmax of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Maximum plasma concentration of CKD-385
- Secondary Outcome Measures
Name Time Method Tmax of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Time to maximum plasma concentration of CKD-385
AUCinf of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Area under the concentration-time curve from zero up to infinity of CKD-385
T1/2 of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Terminal elimination half-life of CKD-385
CL/F of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Apparent clearance of CKD-385
Vd/F of CKD-385 Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours Apparent Volume of Distribution of CKD-385
Trial Locations
- Locations (1)
Central Hospital
🇰🇷Gyeonggi-do, Siheung-si, Korea, Republic of