Pharmacokinetics and Safety Following Administration of DWP16001

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWP16001 drug A; Drug: DWP16001 drug B

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult volunteers aged ≥ 19 years at screening
• Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
• Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
• Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion Criteria:

• Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
• Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
• Clinical laboratory test values are outside the accepted normal range at screening
• Other exclusive inclusion criteria, as defined in the protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence group A; DWP16001 A mg 1T	Drug: DWP16001 drug A; 1 tablet, Oral, once daily single dose; Drug: DWP16001 drug B; 3 tablet, Oral, once daily single dose
Experimental: Sequence group B; DWP16001 B mg 3T	Drug: DWP16001 drug A; 1 tablet, Oral, once daily single dose; Drug: DWP16001 drug B; 3 tablet, Oral, once daily single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0_t of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
Cmax of DWP16001	Peak Plasma Concetration	0-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax Tmax	Time at Cmax Tmax	0-72 hours
AUC of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
T 1/2 of DWP16001	half life of DWP16001	0-72 hours
CL/F of DWP16001	Apparent total clearance of the drug from plasma after oral administration	0-72 hours
Vd/F of DWP16001	Volume of distribution	0-72 hours

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP16001105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No