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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465668
• Other study ID #: DW_DWP16001106
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: July 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 22, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• DWP16001 Drug A
DWP16001 Drug A
• DWP16001 Drug C
DWP16001 Drug C

Locations

Country	Name	City	State
Korea, Republic of	CHA unuversity bundang medical center	Seongnam

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	Cmax,ss of DWP16001	Peak Plasma Concetration of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Primary	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	Tmax of DWP16001	Time at Cmax of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Secondary	T1/2 of DWP16001	Half life of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Secondary	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.
Secondary	Vd/F of DWP16001	Volume of distribution of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.