Skip to main content
OpenTrials
Completed

NCT Number: NCT06889350

Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, 08779, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who are 19 years or older on screening
  • Signed informed consent
  • Healthy Volunteer
  • Other inclusion applies

Exclusion criteria

  • Clinically relevant/significant findings as evaluated by the investigator
  • Other exclusion applied

Treatment and study plan

HD-P023

Drug

Single dose administration of HD-P023

teneligliptin

Drug

Single does administration of Teneligliptin and Empagliflozin High

Empagliflozin High

Drug

Single does administration of Teneligliptin and Empagliflozin High

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin

    Time frame: 72 hours

  2. Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin

    Time frame: 72 hours

Secondary outcomes

  1. AUC∞ of Teneligliptin and Empagliflozin

    Time frame: 72 hours

  2. AUCt/AUC∞ of Teneligliptin and Empagliflozin

    Time frame: 72 hours

  3. Tmax of Teneligliptin and Empagliflozin

    Time frame: 72 hours

  4. VZ/F of Teneligliptin and Empagliflozin

    Time frame: 72 hours

  5. CL/F of Teneligliptin and Empagliflozin

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Jul 31, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.