Pharmacokinetics and Safety Following Administration of DWP16001

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWP16001 drug A; Drug: DWP16001 drug B

• Registration Number: NCT05414591
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence group A	DWP16001 drug A	DWP16001 A mg 1T
Sequence group A	DWP16001 drug B	DWP16001 A mg 1T
Sequence group B	DWP16001 drug A	DWP16001 B mg 3T
Sequence group B	DWP16001 drug B	DWP16001 B mg 3T

Primary Outcome Measures

Name	Time	Method
AUC0_t of DWP16001	0-72 hours	Area under the plasma concentration versus time curve
Cmax of DWP16001	0-72 hours	Peak Plasma Concetration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHA Bundang Medical Center, CHA University; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of