A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6014 and Loose Combination of Each Component in Healthy Adult Volunteers in Fasted Condition

Dong Wha Pharmaceutical Co. Ltd.1 site in 1 country32 target enrollmentFebruary 24, 2023

ConditionsHealthy Subjects

InterventionsDW6014

DrugsDW6014

Overview

Phase: Phase 1
Intervention: DW6014
Conditions: Healthy Subjects
Sponsor: Dong Wha Pharmaceutical Co. Ltd.
Enrollment: 32
Locations: 1
Primary Endpoint: AUC0-t
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 DW6014 and each component in healthy adult volunteers in fast 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

February 24, 2023

End Date

March 20, 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 with a BMI between 18.0 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
•Subject with galactose intolerance, Lapp lactase deficience, glucose-galactose malabsorption or other genetic problem
•Subject following gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of the IP
•Pregnant subjects with a positive urine HCG(human chorionic gonadotropin) test, or lactating female subjects
•Subject with a medical history of hypersensitivity reactions (anaphylaxis or antibiotics etc.) to containing empagliflozin and metformin components, formulation additives, and other drugs (aspirin, antibiotics, biguanide drugs, etc.) or clinically significant hypersensitivity reactions
•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(systolic blood pressure) ≥ 150 mmHg or ≤ 90 mmHg; DBP(diastolic blood pressure) ≥ 100 mmHg or ≤ 60 mmHg; Pulse Rate ≤ 40 bpm or ≥ 100 bpm at the time of screening
•Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
•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