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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DWP16001 Drug C; Drug: DWP16001 Drug A

• Registration Number: NCT05465668
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

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 Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Study Start: 2022-07-22
• Primary Completion: 2022-08-16
• Study Completion: 2022-11-22
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention: DWP16001 Drug C	DWP16001 Drug C	1 tablet, Oral, once daily single dose
Intervention: DWP16001 Drug A	DWP16001 Drug A	1 tablet, Oral, once daily single dose

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHA unuversity bundang medical center; 🇰🇷 Seongnam, Korea, Republic of