Evaluate the Drug-drugs Interaction Between Lobeglitazone 0.5mg and Empagliflozin 25mg

NCT04869800 | Completed Phase 1

• 1 other identifier: A113_01BE2103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-398

  Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

• Cmax of CKD-398

  The maximum concentration observed of CKD-344 over blood sampling time.

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

Secondary Outcomes (5)

• AUCinf of CKD-398

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

• Tmax of CKD-398

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

• T1/2 of CKD-398

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

• CL/F of CKD-398

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

• Vd/F of CKD-398

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose

Study Arms (2)

Sequence 1

EXPERIMENTAL

1. Period 1: Reference drug(CKD-501, D745) 2. Period 2: Test drug(CKD-398)

Drug: CKD-398; Drug: CKD-501, D745

Sequence 2

EXPERIMENTAL

1. Period 1: Test drug(CKD-398) 2. Period 2: Reference drug(CKD-501, D745)

Drug: CKD-398; Drug: CKD-501, D745

Interventions

CKD-398 DRUG

Test Drug

Sequence 1; Sequence 2

CKD-501, D745 DRUG

Reference Drug

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults age≥19 years and age\<55 years at the time of screening
• Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
• \* BMI = Weight(kg)/ Height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
• Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
• Individuals with the ability and willingness to participate the entire study period

You may not qualify if:

• Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
• Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption.
• Individuals with the following laboratory test results at screening:
• ALT or AST \> 2x the upper limit of the normal range
• History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
• Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
• Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
• Following vital signs results at screening
• \- Sitting systolic blood pressure ≥ 140 mmHg or \< 90 mmHg and/or sitting diastolic blood pressure ≥90 mmHg or \<60 mmHg
• Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
• Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
• Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
• Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
• Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
• Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: May 27, 2021
• Primary Completion: June 7, 2021
• Study Completion: June 15, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)