A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CKD-349 F1 Tab.
- Conditions
- Chronic Renal Failure
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- AUCt of CKD-349, D113
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
Detailed Description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults over the age of 19 years at the time of screening
- •Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) \< 29.9kg/m2 and total body weight ≥ 55 kg
- •\* BMI = Weight(kg)/ Height(m)2
- •Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- •Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
- •In case of female subjects, those who were confirmed to be non-pregnant at screening
- •Individuals who agreed to the use of appropriate medically recognized contraceptive methods themselves or their spouse (or partner) from the first administration of the investigational product to the 7th day of last administration. And in case of male subjects, those who agreed not donation of sperm, in case of female subjects, those who agreed not to be pregnant or breast-feeding from the first administration of the investigational product to the 7th day of last administration
- •Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial.
Exclusion Criteria
- •Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- •Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
- •Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- •Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
- •Individuals with hypersensitivity to investigational products or the investigational products ingredients
- •Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than 36hr after discontinuation.
- •Individuals with history of vascular edema in angiotensin-converting enzyme(ACE) inhibitors or angiotensin receptor blocker(ARB) administration
- •Individuals with genetic or idiopathic angioedema
- •Individuals with liver cirrhosis or atresia of bile ducts or cholestasis
- •Individuals with primary hyperaldosteronism
Arms & Interventions
R-T1-T2
1. Period 1: Reference 2. Period 2: Test 1 3. Period 3: Test 2
Intervention: CKD-349 F1 Tab.
R-T1-T2
1. Period 1: Reference 2. Period 2: Test 1 3. Period 3: Test 2
Intervention: CKD-349 F2 Tab.
R-T1-T2
1. Period 1: Reference 2. Period 2: Test 1 3. Period 3: Test 2
Intervention: D113 Tab.
T2-R-T1
1. Period 1: Test 2 2. Period 2: Reference 3. Period 3: Test 1
Intervention: CKD-349 F1 Tab.
T2-R-T1
1. Period 1: Test 2 2. Period 2: Reference 3. Period 3: Test 1
Intervention: CKD-349 F2 Tab.
T2-R-T1
1. Period 1: Test 2 2. Period 2: Reference 3. Period 3: Test 1
Intervention: D113 Tab.
T1-T2-R
1. Period 1: Test 1 2. Period 2: Test 2 3. Period 3: Reference
Intervention: CKD-349 F1 Tab.
T1-T2-R
1. Period 1: Test 1 2. Period 2: Test 2 3. Period 3: Reference
Intervention: CKD-349 F2 Tab.
T1-T2-R
1. Period 1: Test 1 2. Period 2: Test 2 3. Period 3: Reference
Intervention: D113 Tab.
T2-T1-R
1. Period 1: Test 2 2. Period 2: Test 1 3. Period 3: Reference
Intervention: CKD-349 F1 Tab.
T2-T1-R
1. Period 1: Test 2 2. Period 2: Test 1 3. Period 3: Reference
Intervention: CKD-349 F2 Tab.
T2-T1-R
1. Period 1: Test 2 2. Period 2: Test 1 3. Period 3: Reference
Intervention: D113 Tab.
T1-R-T2
1. Period 1: Test 1 2. Period 2: Reference 3. Period 3: Test 2
Intervention: CKD-349 F1 Tab.
T1-R-T2
1. Period 1: Test 1 2. Period 2: Reference 3. Period 3: Test 2
Intervention: CKD-349 F2 Tab.
T1-R-T2
1. Period 1: Test 1 2. Period 2: Reference 3. Period 3: Test 2
Intervention: D113 Tab.
R-T2-T1
1. Period 1: Reference 2. Period 2: Test 2 3. Period 3: Test 1
Intervention: CKD-349 F1 Tab.
R-T2-T1
1. Period 1: Reference 2. Period 2: Test 2 3. Period 3: Test 1
Intervention: CKD-349 F2 Tab.
R-T2-T1
1. Period 1: Reference 2. Period 2: Test 2 3. Period 3: Test 1
Intervention: D113 Tab.
Outcomes
Primary Outcomes
AUCt of CKD-349, D113
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Area under the CKD-349/D113 concentration in blood-time curve from zero to final
Cmax of CKD-349, D113
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
The maximum CKD-349/D113 concentration in blood sampling time t