Teneligliptin and Atorvastatin DDI Study

Phase 1

Completed

• Conditions: Diabete Mellitus
• Interventions: Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day; Drug: Teneligliptin 20mg/day; Drug: Atorvastatin 40mg/Day

• Registration Number: NCT03769870
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2019-01-11
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Teneligliptin + Atorvastatin	Teneligliptin 20mg/day + Atorvastatin 40mg/day	-
Teneligliptin	Teneligliptin 20mg/day	-
Atorvastatin	Atorvastatin 40mg/Day	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss(Maximum concentration at steady state)	24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)	24hours

Trial Locations

Locations (1)

Korea Universitiy Guro Hospital; 🇰🇷 Seoul, Korea, Republic of