Status:
COMPLETED
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)
Lead Sponsor:
LG Chem
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03864432
Start Date
July 2 2019
End Date
February 28 2020
Last Update
March 3 2020
Active Locations (1)
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1
Shanghai Xuhui Central hospital
Shanghai, China, 200002