NCT06339788

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2024

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

March 20, 2024

Last Update Submit

February 3, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

  • Time to peak drug concentration (Tmax) 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

Study Arms (2)

HD-P023

EXPERIMENTAL

One tablet of HD-P023 by oral

Drug: HD-P023

Co-administration of Teneligliptin and Empagliflozin High

ACTIVE COMPARATOR

One tablet each of Teneligliptin and Empagliflozin High by oral

Drug: TeneligliptinDrug: Empagliflozin

Interventions

HD-P023DRUG

Single dose administration of HD-P023

HD-P023
TeneligliptinDRUG

Single does administration of Teneligliptin and Empagliflozin High

Co-administration of Teneligliptin and Empagliflozin High
EmpagliflozinDRUG

Single does administration of Teneligliptin and Empagliflozin High

Co-administration of Teneligliptin and Empagliflozin High

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 19 years or older on screening
  • Signed informed consent
  • Healthy Volunteer

You may not qualify if:

  • Clinically relevant/significant findings as evaluated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Siheung-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidineempagliflozin

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 1, 2024

Study Start

May 10, 2024

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations

KR(1)