Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
- Conditions
- Cardiovascular Diseases
- Interventions
- Drug: Reference drugDrug: Test drug 1Drug: Test drug 2
- Registration Number
- NCT04083846
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.
- 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: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II. Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2 Test drug 2 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 4 Reference drug 1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Group 1 Reference drug 1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2 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 2 Reference drug 1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Group 5 Reference drug 1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 Group 5 Test drug 1 1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2 Group 2 Test drug 1 1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1 Group 3 Test drug 1 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 Test drug 2 1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug Group 6 Test drug 2 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 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 6 Reference drug 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1 Group 6 Test drug 1 1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1
- Primary Outcome Measures
Name Time Method Area Under Curve last(AUCt) Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.
Cmax Pre-dose (0 hour), post-dose 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of