To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers
- Registration Number
- NCT05797922
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- 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.
- A person who is 19 years of age or more at the time of screening.
- 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
- A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DWP16001 to Group A DWP16001 Group A: Fasting in Period 1 / Fed in Period 2 DWP16001 to Group B DWP16001 Group B: Fed in Period 1 / Fasting in Period 2
- Primary Outcome Measures
Name Time Method Cmax of DWP16001 0 to 72 hours Cmax of DWP16001
AUC0-t of DWP16001 0 to 72 hours AUC0-t of DWP16001
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chungbuk National University Hospital
🇰🇷Chungbuk, Korea, Republic of