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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: HD-P023; Drug: Teneligliptin; Drug: Empagliflozin High

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08779
    • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD-P023; One tablet of HD-P023 by oral	Drug: HD-P023; Single dose administration of HD-P023
Active Comparator: Co-administration of Teneligliptin and Empagliflozin High; One tablet each of Teneligliptin and Empagliflozin High by oral	Drug: Teneligliptin; Single does administration of Teneligliptin and Empagliflozin High; Drug: Empagliflozin High; Single does administration of Teneligliptin and Empagliflozin High

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin	72 hours
Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC∞ of Teneligliptin and Empagliflozin	72 hours
AUCt/AUC∞ of Teneligliptin and Empagliflozin	72 hours
Tmax of Teneligliptin and Empagliflozin	72 hours
VZ/F of Teneligliptin and Empagliflozin	72 hours
CL/F of Teneligliptin and Empagliflozin	72 hours

Collaborators and Investigators

• Sponsor: Handok Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): April 13, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: HD-MP-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No