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

April 3, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Chungbuk, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Jun Gi Hwang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWP16001 to Group A
Group A: Fasting in Period 1 / Fed in Period 2
Drug: DWP16001
DWP16001 0.3mg
Other Names:
  • DWP16001 0.3mg
Experimental: DWP16001 to Group B
Group B: Fed in Period 1 / Fasting in Period 2
Drug: DWP16001
DWP16001 0.3mg
Other Names:
  • DWP16001 0.3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-t of DWP16001
Time Frame: 0 to 72 hours
AUC0-t of DWP16001
0 to 72 hours
Cmax of DWP16001
Time Frame: 0 to 72 hours
Cmax of DWP16001
0 to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Chungbuk National University Hospital, Chungbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWP16001109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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