Pharmacokinetic Drug Interaction Between Teneligliptin an... | NCT04431141

Studies
Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

NCT04431141

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Nov 15, 2021Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

Teneligliptin
Empagliflozin
Teneligliptin and Empagliflozin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Nov 16, 2020Actual

Completion Date

Jan 25, 2021Actual

First Submitted Date

Jun 4, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Teneligliptin	Experimental	Drug: Teneligliptin
Empagliflozin	Experimental	Drug: Empagliflozin
Teneligliptin and Empagliflozin	Experimental	Drug: Teneligliptin and Empagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teneligliptin	Drug	Teneligliptin alone	Teneligliptin	Tenelia®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C579035	3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
C570240	empagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided