Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

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

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: DWP16001 Drug A; Drug: DWP16001 Drug C

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • CHA unuversity bundang medical center

Participation Criteria

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:

- 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

☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2

Exclusion Criteria:

• musculoskeletal diseases
• mental diseases
• hemato-oncologic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention: DWP16001 Drug A; 1 tablet, Oral, once daily single dose	Drug: DWP16001 Drug A; DWP16001 Drug A
EXPERIMENTAL: Intervention: DWP16001 Drug C; 1 tablet, Oral, once daily single dose	Drug: DWP16001 Drug C; DWP16001 Drug C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss of DWP16001	Peak Plasma Concetration of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
AUClast of DWP16001	The area under the plasma drug concentration-time curve of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax of DWP16001	Time at Cmax of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
T1/2 of DWP16001	Half life of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
CL/F of DWP16001	Apparent total clearance of the drug from plasma after oral administration of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Vd/F of DWP16001	Volume of distribution of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2022
• Primary Completion (ACTUAL): August 16, 2022
• Study Completion (ACTUAL): November 22, 2022

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP16001106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No