Trials / Completed
CompletedNCT05568121
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers
A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Cross-over Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD1 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, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | L04RD1 | 1 tablet of L04RD1 |
| DRUG | L04TD1 | 1 tablet of L04TD1 |
| DRUG | L04TD1 | 1 tablet of L04TD1 |
| DRUG | L04RD1 | 1 tablet of L04RD1 |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2022-10-09
- Completion
- 2022-10-27
- First posted
- 2022-10-05
- Last updated
- 2023-01-12
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05568121. Inclusion in this directory is not an endorsement.