Teneligliptin-Glimepiride DDI Study

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

Completed

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Treatment and study plan

Teneligliptin+Glimepiride

Drug

Primary outcomes

Peak Plasma Concentration (Cmax)

Time frame: 24hr
Area under the plasma concentration versus time curve (AUC)

Time frame: 24hr

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 4, 2017
Registry last updated: May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed