NCT03851341

Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers

A Randomized, Open-label, Fasting, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GL Pharm Tech Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fasting condition

Detailed description

2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet

Conditions

• Healthy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Janumet XR tablet 100/1000 mg	To administrate the Janumet XR tablet
COMBINATION_PRODUCT	GLH1SM tablet 100/1000 mg	To administrate the GLH1SM tablet

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-01-12
• Completion: 2019-01-18
• First posted: 2019-02-22
• Last updated: 2019-04-24

Locations

1 site across 1 country: South Korea