CClinicalTrials.gg
CompletedNCT03769870Updated May 30, 2019

Teneligliptin and Atorvastatin DDI Study

A Phase 1 interventional study of Teneligliptin 20mg/day and Atorvastatin 40mg/Day in Diabete Mellitus, sponsored by Handok Inc.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Handok Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Diabete Mellitus

Browse trials for

03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Handok Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Teneligliptin

    Drug: Teneligliptin 20mg/day

  • Other
    Atorvastatin

    Drug: Atorvastatin 40mg/Day

  • Other
    Teneligliptin + Atorvastatin

    Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day

Interventions

  • DrugTeneligliptin 20mg/day

    cross-over

  • DrugAtorvastatin 40mg/Day

    cross-over

  • DrugTeneligliptin 20mg/day + Atorvastatin 40mg/day

    cross-over

06

What researchers measure

Primary outcomes

  1. Cmax,ss(Maximum concentration at steady state)

    Time frame: 24 hours

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

    Time frame: 24hours

07

Study locations

1 site
  • Korea Universitiy Guro Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03769870
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Dec 10, 2018
Start date
Jan 11, 2019
Primary completion
Feb 25, 2019
Completion
Feb 25, 2019
Last update
May 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion