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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03864432

Enrollment

Registered

2019-03-06

Start date

2019-07-02

Completion date

2020-02-28

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
AUClast of Gemigliptin	0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Cmax of Gemigliptin	0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026