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

NCT ID: NCT06339788

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2024-06-12

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HD-P023

One tablet of HD-P023 by oral

Group Type EXPERIMENTAL

HD-P023

Intervention Type DRUG

Single dose administration of HD-P023

Co-administration of Teneligliptin and Empagliflozin High

One tablet each of Teneligliptin and Empagliflozin High by oral

Group Type ACTIVE_COMPARATOR

Teneligliptin

Intervention Type DRUG

Single does administration of Teneligliptin and Empagliflozin High

Empagliflozin

Intervention Type DRUG

Single does administration of Teneligliptin and Empagliflozin High

Interventions

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HD-P023

Single dose administration of HD-P023

Intervention Type DRUG

Teneligliptin

Single does administration of Teneligliptin and Empagliflozin High

Intervention Type DRUG

Empagliflozin

Single does administration of Teneligliptin and Empagliflozin High

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Hospital

Siheung-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HD-MP-106

Identifier Type: -

Identifier Source: org_study_id

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