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 Coadministration of Teneligliptin and Empagliflozin High in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07102719

Enrollment

Registered

2025-08-05

Start date

2025-09-10

Completion date

2025-10-20

Last updated

2026-02-05

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

Conditions

Healthy Volunteers

Brief summary

The purpose of this study is to compare the pharmacokinetics and safety of HDP023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers

Interventions

DRUGHD-P023

Single dose administration of HD-P023

DRUGTeneligliptin and Empagliflozin

Single does administration of Teneligliptin and Empagliflozin High

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame
AUC∞ of Teneligliptin and Empagliflozin	72 hours
AUCt/AUC∞ of Teneligliptin and Empagliflozi	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026