Pharmacokinetics and Safety Following Administration of DWP16001

Healthy 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 B in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414591
• Other study ID #: DW_DWP16001105
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2021
• Est. completion date: August 1, 2021

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWP16001 drug A
1 tablet, Oral, once daily single dose
• DWP16001 drug B
3 tablet, Oral, once daily single dose

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

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	AUC0_t of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
Primary	Cmax of DWP16001	Peak Plasma Concetration	0-72 hours
Secondary	Tmax Tmax	Time at Cmax Tmax	0-72 hours
Secondary	AUC of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
Secondary	T 1/2 of DWP16001	half life of DWP16001	0-72 hours
Secondary	CL/F of DWP16001	Apparent total clearance of the drug from plasma after oral administration	0-72 hours
Secondary	Vd/F of DWP16001	Volume of distribution	0-72 hours