NCT05363384

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 25 mg and MET XR 1,000 mg or Administration of CT-L01 25/1,000 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	FDC tablet, single dose, oral administration
DRUG	Alogliptin Benzoate 25 mg	Alogliptin Benzoate 25 mg, oral administration
DRUG	Metformin HCl XR 1,000 mg	Metformin HCl XR 1,000 mg, oral administration

Timeline

• Start date: 2022-06-11
• Primary completion: 2022-06-21
• Completion: 2022-07-12
• First posted: 2022-05-05
• Last updated: 2023-01-12

Locations

1 site across 1 country: South Korea