This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component(Empagliflozin and Metformin) in Healthy Adult Volunteers in Fast Condition.

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: DW6014

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• 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 participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
• Before the first administration date whole blood donation within 2 months or component blood donation within 1 month or received a blood transfusion within 1 month, or the subject who cannot forbid transfusion from the time of obtaining ICF(informed consent form) until PSV(Post-study visit)
• Subjects who have consistently drunk alcohol within 6 months
• Subjects who have smoked more than 10 cigarettes/day on average
• Subjects who have eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV(Post-study visit)
• Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling
• Subjects who have done and are unable to refrain from strenuous activity
• Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception
• Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/exclusion criteria at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: Empagliflozin and Metformin Period 2: DW6014	Drug: DW6014; Drug: DW6014 Single oral administration of DW6014 after an overnight fast Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast; Other Names: Empagliflozin and Metformin
Experimental: Sequence B; Period 1: DW6014 Period 2: Empagliflozin and Metformin	Drug: DW6014; Drug: DW6014 Single oral administration of DW6014 after an overnight fast Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast; Other Names: Empagliflozin and Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	AUC0-t of Empagliflozin and Metformin	48 hour
Cmax	Cmax of Empagliflozin and Metformin	48 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Tmax of Empagliflozin and Metformin	48 hour
t1/2	t1/2 of Empagliflozin and Metformin	48 hour
CL/F	CL/F of Empagliflozin and Metformin	48 hour
Vd/F	Vd/F of Empagliflozin and Metformin	48 hour
AUCinf administration to infinity)	AUCinf of Empagliflozin and Metformin	48 hour

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Empagliflozin
• Other Study ID Numbers: DW6014-I-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No