Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431141
• Other study ID #: MP-C105
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: November 2021
• Source: Handok Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 25, 2021
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Teneligliptin
Teneligliptin alone
• Empagliflozin
Empagliflozin alone
• Teneligliptin and Empagliflozin
Teneligliptin and empagliflozin

Locations

Country	Name	City	State
Korea, Republic of	Clinical Pharmacology, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss of teneligliptin and empagliflozin	Peak Plasma Concentration (Cmax) at steady state	72 hours
Primary	AUCt,ss of teneligliptin and empagliflozin	Area under the plasma concentration versus time curve (AUC) at steady state	72 hours
Secondary	Tmax,ss of teneligliptin and empagliflozin	Time to reach Cmax,ss	72 hours
Secondary	t1/2ß of teneligliptin and empagliflozin	Terminal elimination half-life	72 hours