Study to Evaluate the Safety and PK Properties of DWP16001 in Healthy Subjects With Various Ethnicities

Healthy Clinical Trial

Official title: An Open-label, Single-center, Parallel, Single and Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP16001 in Healthy Koreans, Caucasians, and Hispanics

Status Not yet recruiting

Clinical Trial Summary

An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics

Clinical Trial Description

This study is conducted with single center, parallel design, single and repeated administration and repeated administration.

1. Screening (28d~ 2d) For volunteers, screening tests such as questionnaire, physical examination and clinical examination are conducted within 4 weeks (-28d~-2d) from the date of administration of the clinical investigational drug (1d), and subjects judged to be suitable for this clinical trial are selected.

2. Dosing and Pharmacokinetics/Pharmacodynamic Evaluators (1d to 12d) The subjects who are judged to be suitable for this clinical trial are admitted to the clinical trial center of Seoul National University Hospital in the afternoon of 1 day (-1d) before administration. In order to maintain an empty stomach for at least 10 hours before administration of clinical trial drugs, fast except for drinking water after 10 p.m.

3. PSV (17d ~ 21d) The post-study visit is conducted on 17d to 21d, about one week after the last dosing date. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05207176
• Study type: Interventional
• Source: Daewoong Pharmaceutical Co. LTD.
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 14, 2022
• Completion date: August 31, 2022