Teneligliptin and Atorvastatin DDI Study

May 28, 2019 updated by: Handok Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Teneligliptin
Drug: Teneligliptin 20mg/day
cross-over
OTHER: Atorvastatin
Drug: Atorvastatin 40mg/Day
cross-over
OTHER: Teneligliptin + Atorvastatin
Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day
cross-over

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss(Maximum concentration at steady state)
Time Frame: 24 hours
24 hours
AUCτ,ss(Area under the concentration-time curve at steady state)
Time Frame: 24hours
24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 11, 2019

Primary Completion (ACTUAL)

February 25, 2019

Study Completion (ACTUAL)

February 25, 2019

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (ACTUAL)

December 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP_C104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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