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)
NCT ID: NCT03864432
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2019-07-02
2020-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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25mg SAD
Gemigliptin 25mg
Gemigliptin 50mg 1/2T
50mg SAD
Gemigliptin 50mg
Gemigliptin 50mg 1T
100mg SAD
Gemigliptin 100mg
Gemigliptin 50mg 2T
50mg Multiple dosing
Gemiglptin 50mg multiple dose
Gemigliptin 50mg 1T \* 10days
Interventions
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Gemigliptin 25mg
Gemigliptin 50mg 1/2T
Gemigliptin 50mg
Gemigliptin 50mg 1T
Gemigliptin 100mg
Gemigliptin 50mg 2T
Gemiglptin 50mg multiple dose
Gemigliptin 50mg 1T \* 10days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
45 Years
ALL
Yes
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Principal Investigators
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Yan-Mei Liu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Xuhui District Central Hospital
Locations
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Shanghai Xuhui Central hospital
Shanghai, , China
Countries
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Other Identifiers
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LG-DPCL020
Identifier Type: -
Identifier Source: org_study_id
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