A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6013 and Loose Combination of Each Component in Healthy Adult Volunteers in Fed Condition

Dong Wha Pharmaceutical Co. Ltd.1 site in 1 country31 target enrollmentJanuary 9, 2023

ConditionsHealthy Subjects

InterventionsDW6013

DrugsDW6013

Overview

Phase: Phase 1
Intervention: DW6013
Conditions: Healthy Subjects
Sponsor: Dong Wha Pharmaceutical Co. Ltd.
Enrollment: 31
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fed condition.

Detailed Description

This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects

Registry

clinicaltrials.gov

Start Date

January 9, 2023

End Date

February 3, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Dong Wha Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects aged up to 19 years
•Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2
•Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
•Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics
•Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period

Exclusion Criteria

•Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history
•Pregnant subjects with a positive urine HCG test, or lactating female subjects
•Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
•Subjects with clinically significant 12-lead ECG findings at the time of screening
•Subjects with a past history of drug abuse or a positive urine drug test
•Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening
•Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
•Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days
•Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
•Subjects who have consistently drunk alcohol within 6 months