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NCT05364164
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
Phase 1 trial testing CT-L01 12.5/1,000 mg in Healthy in 24 participants. Completed in 25 July 2022.
19 July 2022
Quick facts
| Lead sponsor | Celltrion |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 9 July 2022 |
| Primary completion | 19 July 2022 |
| Estimated completion | 25 July 2022 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- CT-L01 12.5/1,000 mg — full drug profile →
- CT-L01 12.5/1,000 mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Celltrion — full company profile →
Who can join
Adults 19 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05364164
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05364164 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celltrion
- Last refreshed: 12 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05364164.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing