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.

NCT ID: NCT05823870

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2023-03-20

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A

Period 1: Empagliflozin and Metformin Period 2: DW6014

Group Type: EXPERIMENTAL

DW6014

Intervention Type: DRUG

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

Sequence B

Period 1: DW6014 Period 2: Empagliflozin and Metformin

Group Type: EXPERIMENTAL

DW6014

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Empagliflozin and Metformin

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
• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong Wha Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungbuk National University Hospital

Cheongju-si, , South Korea

Countries

South Korea

Other Identifiers

DW6014-I-1

Identifier Type: -

Identifier Source: org_study_id