NCT07128654

A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate the Safety and Pharmacokinetics After Co-administration of CTL0201 and CTL0202 or Administration of CT-L02 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Days – 55 Days
• Healthy volunteers: Accepted

Summary

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CTL02	FDC tablet, single dose, oral administration
DRUG	CTL0201	Nesina, tablet, single dose, oral administration
DRUG	CTL0202	Jardiance, tablet, single dose, oral administration

Timeline

• Start date: 2025-09-17
• Primary completion: 2025-10-05
• Completion: 2025-10-26
• First posted: 2025-08-19
• Last updated: 2025-11-17

Locations

1 site across 1 country: South Korea