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)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864432
• Other study ID #: LG-DPCL020
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 28, 2020
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Gemigliptin 25mg
Gemigliptin 50mg 1/2T
• Gemigliptin 50mg
Gemigliptin 50mg 1T
• Gemigliptin 100mg
Gemigliptin 50mg 2T
• Gemiglptin 50mg multiple dose
Gemigliptin 50mg 1T * 10days

Locations

Country	Name	City	State
China	Shanghai Xuhui Central hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

China, 

Outcome

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