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

Handok Inc.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

HD-P023DRUG

Single dose administration of HD-P023

TeneligliptinDRUG

Single does administration of Teneligliptin and Empagliflozin High

EmpagliflozinDRUG

Single does administration of Teneligliptin and Empagliflozin High

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Central Hospital

Siheung-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Secondary Outcomes

Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Clearance (CL/F) of Teneligliptin and Empagliflozin

Time frame: 72 hours

Data from ClinicalTrials.gov

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