Healthy
Conditions
Brief summary
This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.
Detailed description
The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.
Interventions
DRUGDWP16001
DWP16001 0.3mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. 2. A person who is 19 years of age or more at the time of screening. 3. Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
Exclusion criteria
1. A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 2. A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t of DWP16001 | 0 to 72 hours | AUC0-t of DWP16001 |
| Cmax of DWP16001 | 0 to 72 hours | Cmax of DWP16001 |
Countries
South Korea
Contacts
Primary ContactDaewoong Pharmaceutical
Outcome results
None listed