NCT05703984

A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: GC Biopharma Corp · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GC2129A(Period 1)	Linagliptin and Metformin Hydrochloride Tablet
DRUG	Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1)	Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)
DRUG	GC2129A(Period 2)	Linagliptin and Metformin Hydrochloride Tablet
DRUG	Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2)	Linagliptin 5mg/tab and Metformin Hydrochloride 1000mg/tab (2 tablets)

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-04-19
• Completion: 2023-04-19
• First posted: 2023-01-30
• Last updated: 2023-01-30

Locations

1 site across 1 country: South Korea