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

Phase 1

Completed

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

• Registration Number: NCT06339788
• 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

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-01
• Study Start: 2024-05-10
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• 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	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
Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin	72 hours
Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin	72 hours
Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin	72 hours
Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin	72 hours
Clearance (CL/F) of Teneligliptin and Empagliflozin	72 hours

Trial Locations

Locations (1)

Central Hospital; 🇰🇷 Siheung-si, Gyeonggi-do, Korea, Republic of