Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Empagliflozin; Drug: Teneligliptin; Drug: Teneligliptin and Empagliflozin

• Registration Number: NCT04431141
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-09-15
• Primary Completion: 2020-11-16
• Study Completion: 2021-01-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin	-
Teneligliptin	Teneligliptin	-
Teneligliptin and Empagliflozin	Teneligliptin and Empagliflozin	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss of teneligliptin and empagliflozin	72 hours	Peak Plasma Concentration (Cmax) at steady state
AUCτ,ss of teneligliptin and empagliflozin	72 hours	Area under the plasma concentration versus time curve (AUC) at steady state

Secondary Outcome Measures

Name	Time	Method
Tmax,ss of teneligliptin and empagliflozin	72 hours	Time to reach Cmax,ss
t1/2β of teneligliptin and empagliflozin	72 hours	Terminal elimination half-life

Trial Locations

Locations (1)

Clinical Pharmacology, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of