NCT03009513

Brief Summary

An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

December 28, 2016

Last Update Submit

April 30, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    24hr

  • Area under the plasma concentration versus time curve (AUC)

    24hr

Study Arms (1)

single arm

EXPERIMENTAL
Drug: Teneligliptin+Glimepiride

Interventions

Teneligliptin+GlimepirideDRUG
single arm

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male adult aged 20 to 45 years
  • Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening
  • Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
  • Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04