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

• ClinicalTrials.gov Identifier: NCT04869800
• Recruitment Status: Completed
• First Posted: May 3, 2021
• Last Update Posted: August 25, 2021
• Sponsor: Chong Kun Dang Pharmaceutical
• Information provided by (Responsible Party): Chong Kun Dang Pharmaceutical

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: CKD-398; Drug: CKD-501, D745	Phase 1

Detailed Description:

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-398 in healthy volunteers under fasting conditions

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-398 in Healthy Volunteers Under Fasting Conditions
• Actual Study Start Date: May 27, 2021
• Actual Primary Completion Date: June 7, 2021
• Actual Study Completion Date: June 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sequence 1; Period 1: Reference drug(CKD-501, D745); Period 2: Test drug(CKD-398)	Drug: CKD-398; Test Drug; Drug: CKD-501, D745; Reference Drug
Experimental: Sequence 2; Period 1: Test drug(CKD-398); Period 2: Reference drug(CKD-501, D745)	Drug: CKD-398; Test Drug; Drug: CKD-501, D745; Reference Drug

Outcome Measures

Primary Outcome Measures :

1. AUCt of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.
2. Cmax of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   The maximum concentration observed of CKD-344 over blood sampling time.

Secondary Outcome Measures :

1. AUCinf of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Area under the concentration-time curve from zero up to ∞
2. Tmax of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Time to maximum plasma concentration
3. T1/2 of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Terminal elimination half-life
4. CL/F of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Apparent Clearance
5. Vd/F of CKD-398 [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose ]
   Apparent volume of distribution

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 54 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Healthy adults age≥19 years and age<55 years at the time of screening

2. 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

3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
4. 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
5. 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
6. 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
7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria:

1. 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.
2. 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.

3. Individuals with the following laboratory test results at screening:

   • ALT or AST > 2x the upper limit of the normal range

4. 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)
5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
6. 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

7. 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

8. Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
9. 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)
10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
11. 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)
12. 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
13. Individuals with hypersensitivity to investigational products or the investigational products ingredients or dihydropyridine drugs
14. Subject had severe heart failure(NYHA class 1, 2, 3, 4)
15. Patients with hepatopathy
16. Patients with diabetic ketogenic acidosis, diabetic comas and ex-coma, type 1 diabetes.
17. Before and after surgery, severe infections, severe trauma.
18. Patients with edema
19. Subject had renal impairment(eGFR < 60 mL/min/1.73 m²)
20. Subject who is a pregnant or nursing woman
21. Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
22. Subjects who were deemed inappropriate to participate in the study by the investigator

Contacts and Locations

Locations

Korea, Republic of

Chonbuk National University Hospital

Jeonju, Korea, Republic of

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

More Information

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04869800
• Other Study ID Numbers: A113_01BE2103
• First Posted: May 3, 2021
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases