Healthy Volunteers
Conditions
Brief summary
This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.
Detailed description
The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).
Interventions
DRUGDWP16001
DWP16001 A mg
DRUGDWP202010
DWP202010 B mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax,ss) of DWP16001 | Before IP administration of Day 1, Day 5, and Day 6 |
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 | Before IP administration of Day 1, Day 5, and Day 6 |
| Peak Plasma Concentration (Cmax,ss) of DWC202010 | Before IP administration and post-dose up to 24 hours |
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 | Before IP administration and post-dose up to 24 hours |
Countries
South Korea
Outcome results
None listed