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)

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

Official Title
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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)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Gemigliptin 25mg
* Drug: Gemigliptin 50mg
* Drug: Gemigliptin 100mg
* Drug: Gemiglptin 50mg multiple dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25mg SAD<br> | Drug: Gemigliptin 25mg<br>* Gemigliptin 50mg 1/2T<br>|
| Experimental: 50mg SAD<br> | Drug: Gemigliptin 50mg<br>* Gemigliptin 50mg 1T<br>|
| Experimental: 100mg SAD<br> | Drug: Gemigliptin 100mg<br>* Gemigliptin 50mg 2T<br>|
| Experimental: 50mg Multiple dosing<br> | Drug: Gemiglptin 50mg multiple dose<br>* Gemigliptin 50mg 1T * 10days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |