Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

Study Overview
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Brief Summary
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This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.

Official Title
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A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Teneligliptin
* Drug: Empagliflozin
* Drug: Teneligliptin and Empagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions Exclusion Criteria: History of type 1 diabetes mellitus and/or diabetic ketoacidosis Severe infection, surgery, or severe trauma within 6 months prior to the screening visit Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study Subject determined by the principal investigator to be ineligible for study conduct for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin<br> | Drug: Teneligliptin<br>* Teneligliptin alone<br>* Other names: Tenelia®;|
| Experimental: Empagliflozin<br> | Drug: Empagliflozin<br>* Empagliflozin alone<br>* Other names: Jardiance®;|
| Experimental: Teneligliptin and Empagliflozin<br> | Drug: Teneligliptin and Empagliflozin<br>* Teneligliptin and empagliflozin<br>* Other names: Tenelia® and Jardiance®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of teneligliptin and empagliflozin | Peak Plasma Concentration (Cmax) at steady state | 72 hours | 
| AUCτ,ss of teneligliptin and empagliflozin | Area under the plasma concentration versus time curve (AUC) at steady state | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss of teneligliptin and empagliflozin | Time to reach Cmax,ss | 72 hours | 
| t1/2β of teneligliptin and empagliflozin | Terminal elimination half-life | 72 hours |