Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

November 8, 2021 updated by: Handok Inc.

A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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 Locations

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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,ss of teneligliptin and empagliflozin
Time Frame: 72 hours
Peak Plasma Concentration (Cmax) at steady state
72 hours
AUCτ,ss of teneligliptin and empagliflozin
Time Frame: 72 hours
Area under the plasma concentration versus time curve (AUC) at steady state
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax,ss of teneligliptin and empagliflozin
Time Frame: 72 hours
Time to reach Cmax,ss
72 hours
t1/2β of teneligliptin and empagliflozin
Time Frame: 72 hours
Terminal elimination half-life
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 (Actual)

September 15, 2020

Primary Completion (Actual)

November 16, 2020

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-C105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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Locations

3
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