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CompletedNCT03009513Updated May 2, 2018

Teneligliptin-Glimepiride DDI Study

A Phase 1 interventional study of Teneligliptin+Glimepiride in Diabetes Mellitus, sponsored by Handok Inc.. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.

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

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 26 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
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male adult aged 20 to 45 years
  2. Body weight ≥ 50kg, and BMI between 18 and 29 kg/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

Exclusion Criteria:

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    single arm

    Drug: Teneligliptin+Glimepiride

Interventions

  • DrugTeneligliptin+Glimepiride
06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 24hr

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 24hr

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03009513
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Jan 4, 2017
Start date
Jan 2017
Primary completion
May 2017
Completion
Jun 2017
Last update
May 2, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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