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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: HD-P023; Drug: Teneligliptin; Drug: Empagliflozin High

• Registration Number: NCT06889350
• Lead Sponsor: Handok Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HD-P023	HD-P023	One tablet of HD-P023 by oral
Co-administration of Teneligliptin and Empagliflozin High	Teneligliptin	One tablet each of Teneligliptin and Empagliflozin High by oral
Co-administration of Teneligliptin and Empagliflozin High	Empagliflozin High	One tablet each of Teneligliptin and Empagliflozin High by oral

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of