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

March 31, 2024 updated by: Handok Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD-P023
One tablet of HD-P023 by oral
Drug: HD-P023
Single dose administration of HD-P023
Active Comparator: Co-administration of Teneligliptin and Empagliflozin High
One tablet each of Teneligliptin and Empagliflozin High by oral
Drug: Teneligliptin
Single does administration of Teneligliptin and Empagliflozin High
Drug: Empagliflozin
Single does administration of Teneligliptin and Empagliflozin High

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
Time Frame: 72 hours
72 hours
Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-MP-106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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