Teneligliptin and Atorvastatin DDI Study

Handok Inc.30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabete Mellitus

Interventions

Teneligliptin 20mg/dayDRUG

cross-over

Atorvastatin 40mg/DayDRUG

cross-over

Teneligliptin 20mg/day + Atorvastatin 40mg/dayDRUG

cross-over

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy male adult 19 to 45 years 2. Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening 3. 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. 4. 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.

Locations (1)

Korea Universitiy Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax,ss(Maximum concentration at steady state)

Time frame: 24 hours

AUCτ,ss(Area under the concentration-time curve at steady state)

Time frame: 24hours

Data from ClinicalTrials.gov

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