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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)

NCT03864432 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-03-03

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Gemigliptin 25mg

Gemigliptin 50mg 1/2T

DRUG

Gemigliptin 50mg

Gemigliptin 50mg 1T

DRUG

Gemigliptin 100mg

Gemigliptin 50mg 2T

DRUG

Gemiglptin 50mg multiple dose

Gemigliptin 50mg 1T \* 10days

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Yan-Mei Liu · Shanghai Xuhui District Central Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2019-10-03
Completion
2020-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864432 on ClinicalTrials.gov