A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- AUClast of DWP16001
Study Overview
Brief Summary
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.
Detailed Description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.
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
- •Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- •☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2
Exclusion Criteria
- •musculoskeletal diseases
- •mental diseases
- •hemato-oncologic diseases
Arms & Interventions
Intervention: DWP16001 Drug A
1 tablet, Oral, once daily single dose
Intervention: DWP16001 Drug A (Drug)
Intervention: DWP16001 Drug C
1 tablet, Oral, once daily single dose
Intervention: DWP16001 Drug C (Drug)
Outcomes
Primary Outcomes
AUClast of DWP16001
Time Frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
The area under the plasma drug concentration-time curve of DWP16001
Cmax,ss of DWP16001
Time Frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Peak Plasma Concetration of DWP16001
Secondary Outcomes
- CL/F of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- T1/2 of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- Vd/F of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)
- Tmax of DWP16001(At pre-dose (0 hour), and post-dose 0.25 to 72 hour.)