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Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

Sponsor
Handok Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04431141
Collaborator
(none)
32
Enrollment
1
Location
3
Arms
4.3
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Nov 16, 2020
Actual Study Completion Date :
Jan 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Teneligliptin

Drug: Teneligliptin
Teneligliptin alone
Other Names:
  • Tenelia®

    		•
    Experimental: Empagliflozin

    Drug: Empagliflozin
    Empagliflozin alone
    Other Names:
  • Jardiance®

    		•
    Experimental: Teneligliptin and Empagliflozin

    Drug: Teneligliptin and Empagliflozin
    Teneligliptin and empagliflozin
    Other Names:
  • Tenelia® and Jardiance®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax,ss of teneligliptin and empagliflozin [72 hours]

      Peak Plasma Concentration (Cmax) at steady state

    2. AUCτ,ss of teneligliptin and empagliflozin [72 hours]

      Area under the plasma concentration versus time curve (AUC) at steady state

    Secondary Outcome Measures

    1. Tmax,ss of teneligliptin and empagliflozin [72 hours]

      Time to reach Cmax,ss

    2. t1/2β of teneligliptin and empagliflozin [72 hours]

      Terminal elimination half-life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit

    • Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit

    • Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

    Exclusion Criteria:

    • History of type 1 diabetes mellitus and/or diabetic ketoacidosis

    • Severe infection, surgery, or severe trauma within 6 months prior to the screening visit

    • Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

    • Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit

    • Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study

    • Subject determined by the principal investigator to be ineligible for study conduct for other reasons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Pharmacology, Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Handok Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Handok Inc.
    ClinicalTrials.gov Identifier:
    NCT04431141
    Other Study ID Numbers:
    • MP-C105
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Empagliflozin

    Study Results

    No Results Posted as of Nov 15, 2021