A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
Overview
- Phase
- Phase 1
- Intervention
- Test drug 2
- Conditions
- Cardiovascular Diseases
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area Under Curve last(AUCt)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2
Intervention: Test drug 2
Group 2
1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1
Intervention: Reference drug
Group 1
1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2
Intervention: Reference drug
Group 1
1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2
Intervention: Test drug 1
Group 2
1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1
Intervention: Test drug 1
Group 2
1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1
Intervention: Test drug 2
Group 3
1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug
Intervention: Reference drug
Group 3
1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug
Intervention: Test drug 1
Group 3
1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug
Intervention: Test drug 2
Group 4
1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug
Intervention: Reference drug
Group 4
1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug
Intervention: Test drug 1
Group 4
1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug
Intervention: Test drug 2
Group 5
1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2
Intervention: Reference drug
Group 5
1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2
Intervention: Test drug 1
Group 5
1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2
Intervention: Test drug 2
Group 6
1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1
Intervention: Reference drug
Group 6
1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1
Intervention: Test drug 1
Group 6
1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1
Intervention: Test drug 2
Outcomes
Primary Outcomes
Area Under Curve last(AUCt)
Time Frame: 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
Time Frame: 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.