NCT05581693

A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers

A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD2 and L04RD1 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	L04RD1	1 tablet of L04RD1
DRUG	L04TD2	1 tablet of L04TD2
DRUG	L04TD2	1 tablet of L04TD2
DRUG	L04RD1	1 tablet of L04RD1

Timeline

• Start date: 2022-09-30
• Primary completion: 2022-11-01
• Completion: 2022-11-29
• First posted: 2022-10-14
• Last updated: 2023-01-12

Locations

1 site across 1 country: South Korea