Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

NCT04431141 | Completed Phase 1

• 1 other identifier: MP-C105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Cmax,ss of teneligliptin and empagliflozin

  Peak Plasma Concentration (Cmax) at steady state

  72 hours

• AUCτ,ss of teneligliptin and empagliflozin

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

  72 hours

Secondary Outcomes (2)

• Tmax,ss of teneligliptin and empagliflozin

  72 hours

• t1/2β of teneligliptin and empagliflozin

  72 hours

Study Arms (3)

Teneligliptin

EXPERIMENTAL

Drug: Teneligliptin

Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin

Teneligliptin and Empagliflozin

EXPERIMENTAL

Drug: Teneligliptin and Empagliflozin

Interventions

Teneligliptin DRUG

Teneligliptin alone

Also known as: Tenelia®

Teneligliptin

Empagliflozin DRUG

Empagliflozin alone

Also known as: Jardiance®

Empagliflozin

Teneligliptin and Empagliflozin DRUG

Teneligliptin and empagliflozin

Also known as: Tenelia® and Jardiance®

Teneligliptin and Empagliflozin

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Clinical Pharmacology, Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: September 15, 2020
• Primary Completion: November 16, 2020
• Study Completion: January 25, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)