A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults

Handok Inc.1 site in 1 country30 target enrollmentJanuary 11, 2019

ConditionsDiabete Mellitus

InterventionsTeneligliptin 20mg/day Atorvastatin 40mg/Day Teneligliptin 20mg/day + Atorvastatin 40mg/day

DrugsTeneligliptin 20mg/day Atorvastatin 40mg/Day Teneligliptin 20mg/day + Atorvastatin 40mg/day

Overview

Phase: Phase 1
Intervention: Teneligliptin 20mg/day
Conditions: Diabete Mellitus
Sponsor: Handok Inc.
Enrollment: 30
Locations: 1
Primary Endpoint: Cmax,ss(Maximum concentration at steady state)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults

Registry

clinicaltrials.gov

Start Date

January 11, 2019

End Date

February 25, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Handok Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male adult 19 to 45 years
•Body weight ≥ 50kg, and BMI between 18-29kg/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.