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Pharmacokinetics 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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06339788
Enrollment
40
Registered
2024-04-01
Start date
2024-05-10
Completion date
2024-06-12
Last updated
2025-02-04

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 HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers

Interventions

DRUGHD-P023

Single dose administration of HD-P023

DRUGTeneligliptin

Single does administration of Teneligliptin and Empagliflozin High

DRUGEmpagliflozin

Single does administration of Teneligliptin and Empagliflozin High

Sponsors

Handok Inc.
Lead SponsorINDUSTRY

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

MeasureTime frame
Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin72 hours
Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin72 hours

Secondary

MeasureTime frame
Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin72 hours
Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin72 hours
Clearance (CL/F) of Teneligliptin and Empagliflozin72 hours
Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin72 hours
Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin72 hours

Countries

South Korea

Outcome results

None listed

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