To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DWP16001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05797922

DW_DWP16001109

Details and patient eligibility

About

This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.

Full description

The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.

Enrollment: 32 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

DWP16001 to Group A

Experimental group

Description:

Group A: Fasting in Period 1 / Fed in Period 2

Treatment:

Drug: DWP16001

DWP16001 to Group B

Experimental group

Description:

Group B: Fed in Period 1 / Fasting in Period 2

Treatment:

Drug: DWP16001