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

Sponsor
Handok Inc.
Study ID
NCT06889350
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • HD-P023 — DRUG
    Single dose administration of HD-P023
  • Teneligliptin — DRUG
    Single does administration of Teneligliptin and Empagliflozin High
  • Empagliflozin High — DRUG
    Single does administration of Teneligliptin and Empagliflozin High

Study Details

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

Key Dates

Start date
Mar 26, 2025
Status verified
Jul 2025
Primary completion
Apr 13, 2025
Completion
May 7, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HD-P023
    One tablet of HD-P023 by oral
  • Active Comparator: Co-administration of Teneligliptin and Empagliflozin High
    One tablet each of Teneligliptin and Empagliflozin High by oral

Primary Outcome Measure

Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin [ Time Frame: 72 hours ]

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