Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions

GC Biopharma Corp1 site in 1 country50 target enrollmentJanuary 17, 2023

InterventionsGC2129A(Period 1)Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)GC2129A(Period 2)

DrugsGC2129A(Period 1)Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)GC2129A(Period 2)Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)

Overview

Phase: Phase 1
Intervention: GC2129A(Period 1)
Conditions: Healthy Volunteers
Sponsor: GC Biopharma Corp
Enrollment: 50
Locations: 1
Primary Endpoint: Pharmacokinetic (PK) parameters - Cmax
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.

Detailed Description

This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered. For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.

Registry

clinicaltrials.gov

Start Date

January 17, 2023

End Date

April 19, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GC Biopharma Corp

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A person who is 19 years of age or older at the time of a screening visit
•A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
•A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination

Exclusion Criteria

•Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
•A person who has a history of gastrointestinal surgery
•Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
•A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
•A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
•A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria
•In the case of female volunteers, a pregnant woman or pregnant woman is suspected