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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Area Under Curve last(AUCt)
Study Overview
Brief Summary
This study is a randomized, open-label, fasting, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions.
Detailed Description
To 16 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D744 Test drug: CKD-385 64 mg formulation I Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
- Period 1: Reference drug
- Period 2: Test drug
Intervention: Reference drug (Drug)
Group 1
- Period 1: Reference drug
- Period 2: Test drug
Intervention: Test drug (Drug)
Group 2
- Period 1: Test drug
- Period 2: Reference drug
Intervention: Reference drug (Drug)
Group 2
- Period 1: Test drug
- Period 2: Reference drug
Intervention: Test drug (Drug)
Outcomes
Primary Outcomes
Area Under Curve last(AUCt)
Time Frame: Pre-dose (0 hour), post-dose 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 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 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 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 Outcomes
No secondary outcomes reported