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CompletedNCT03864432Updated Mar 3, 2020

An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)

A Phase 1 interventional study of Gemigliptin 25mg and Gemigliptin 50mg in Type 2 Diabetes Mellitus, sponsored by LG Chem. Completed at 1 site in China. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by LG Chem · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Healthy male and female subjects (aged 19\~45 years at the time of screening)
  • Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
  • Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
  • Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.

Exclusion criteria

Exclusion Criteria:

  • Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
  • Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
  • Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    25mg SAD

    Drug: Gemigliptin 25mg

  • Experimental
    50mg SAD

    Drug: Gemigliptin 50mg

  • Experimental
    100mg SAD

    Drug: Gemigliptin 100mg

  • Experimental
    50mg Multiple dosing

    Drug: Gemiglptin 50mg multiple dose

Interventions

  • DrugGemigliptin 25mg

    Gemigliptin 50mg 1/2T

  • DrugGemigliptin 50mg

    Gemigliptin 50mg 1T

  • DrugGemigliptin 100mg

    Gemigliptin 50mg 2T

  • DrugGemiglptin 50mg multiple dose

    Gemigliptin 50mg 1T \* 10days

06

What researchers measure

Primary outcomes

  1. AUClast of Gemigliptin

    Time frame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h

  2. Cmax of Gemigliptin

    Time frame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h

07

Study locations

1 site
  • Shanghai Xuhui Central hospital
    Shanghai, 200002, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03864432
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Mar 6, 2019
Start date
Jul 2, 2019
Primary completion
Oct 3, 2019
Completion
Feb 28, 2020
Last update
Mar 3, 2020

Study contacts

Yan-Mei Liu
principal investigator · Shanghai Xuhui District Central Hospital

Oversight

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 Mar 2020. You cannot join it, but the record below documents what was studied.

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