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NCT05797922 Clinical Trial

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

Healthy Clinical Trial

Official title:
A Phase 1 Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics and Safety of DWP16001 After Administration in Healthy Adult Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05797922
Other study ID # DW_DWP16001109
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 9, 2023
Est. completion date November 30, 2023

Study information
Verified date March 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact Daewoong Pharmaceutical
Phone 080-550-8308
Email yoonhye@daewoong.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date November 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWP16001
DWP16001 0.3mg

Locations
Country Name City State
Korea, Republic of Chungbuk National University Hospital Chungbuk

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC0-t of DWP16001 AUC0-t of DWP16001 0 to 72 hours
Primary Cmax of DWP16001 Cmax of DWP16001 0 to 72 hours
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