NCT05364164

A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers

A Phase I, Randomized, Open-Label, Single-Dose, Crossover Study to Evaluate Food Effect on the Pharmacokinetics and Safety of CT-L01 After Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CT-L01 12.5/1,000 mg	FDC tablet, 2 tablets at a time, oral administration, dosing under fasting condition
DRUG	CT-L01 12.5/1,000 mg	FDC tablet, 2 tablets at a time, oral administration, dosing after high-fat meal

Timeline

• Start date: 2022-07-09
• Primary completion: 2022-07-19
• Completion: 2022-07-25
• First posted: 2022-05-06
• Last updated: 2023-01-12

Locations

1 site across 1 country: South Korea