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Completed

NCT Number: NCT04431141

Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

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

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Key information

Conditions

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

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology, Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

teneligliptin

Drug

Teneligliptin alone

Other names: Tenelia®

Empagliflozin

Drug

Empagliflozin alone

Other names: Jardiance®

Teneligliptin and Empagliflozin

Drug

Teneligliptin and empagliflozin

Other names: Tenelia® and Jardiance®

Primary outcomes

  1. Cmax,ss of teneligliptin and empagliflozin

    Time frame: 72 hours

    Peak Plasma Concentration (Cmax) at steady state

  2. AUCτ,ss of teneligliptin and empagliflozin

    Time frame: 72 hours

    Area under the plasma concentration versus time curve (AUC) at steady state

Secondary outcomes

  1. Tmax,ss of teneligliptin and empagliflozin

    Time frame: 72 hours

    Time to reach Cmax,ss

  2. t1/2β of teneligliptin and empagliflozin

    Time frame: 72 hours

    Terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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