NCT05363592

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CT-L01 12.5/500 mg	FDC tablet, 2 tablets at a time, oral administration
DRUG	Alogliptin Benzoate 12.5 mg	Alogliptin Benzoate 12.5 mg 2 tablets, at a time, oral administration
DRUG	Metformin HCl XR 500 mg	Metformin HCl XR 500 mg 2 tablets, at a time, oral administration

Timeline

• Start date: 2022-06-25
• Primary completion: 2022-07-05
• Completion: 2022-07-25
• First posted: 2022-05-06
• Last updated: 2023-01-12

Locations

1 site across 1 country: South Korea