Status:

COMPLETED

Teneligliptin and Atorvastatin DDI Study

Lead Sponsor:

Handok Inc.

Conditions:

Diabete Mellitus

Eligibility:

MALE

19-45 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 11 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 25 2019

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT03769870

    Start Date

    January 11 2019

    End Date

    February 25 2019

    Last Update

    May 30 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Korea Universitiy Guro Hospital

    Seoul, South Korea