Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
Study Overview
Brief Summary
This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Volunteers who are ≥19 years and >65 years old
- •Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2
Exclusion Criteria
- •Clinically significant Medical History
- •In the case of women, pregnant(Urine-HCG positive) or lactating women
Arms & Interventions
Sequence D
cross-over
Intervention: DW5124 (Drug)
Sequence D
cross-over
Intervention: DW5124-R (Drug)
Sequence E
cross-over
Intervention: DW5124 (Drug)
Sequence E
cross-over
Intervention: DW5124-R (Drug)
Sequence F
cross-over
Intervention: DW5124 (Drug)
Sequence F
cross-over
Intervention: DW5124-R (Drug)
Sequence B
cross-over
Intervention: DW5124 (Drug)
Sequence B
cross-over
Intervention: DW5124-R (Drug)
Sequence C
cross-over
Intervention: DW5124 (Drug)
Sequence C
cross-over
Intervention: DW5124-R (Drug)
Sequence A
cross-over
Intervention: DW5124 (Drug)
Sequence A
cross-over
Intervention: DW5124-R (Drug)
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: up to 72 hour
Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed
Area under the plasma concentration versus time curve (AUC)
Time Frame: up to 72 hour
Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed
Secondary Outcomes
- Time to maximum plasma concentration (Tmax)(up to 72 hour)
- Terminal half life (t1/2)(up to 72 hour)
- Apparent clearance (CL/F)(up to 72 hour)
- Apparent volume of distribution (Vd/F)(up to 72 hour)