Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04431141

Enrollment

Registered

2020-06-16

Start date

2020-09-15

Completion date

2021-01-25

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGTeneligliptin

Teneligliptin alone

DRUGEmpagliflozin

Empagliflozin alone

DRUGTeneligliptin and Empagliflozin

Teneligliptin and empagliflozin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026