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NCT05002244
A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers
Phase 1 trial testing CTL0801 (Azilsartan) in Health, Subjective in 37 participants. Completed in 13 September 2021.
29 August 2021
Quick facts
| Lead sponsor | Celltrion |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 23 July 2021 |
| Primary completion | 29 August 2021 |
| Estimated completion | 13 September 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- CTL0801 (Azilsartan) — full drug profile →
- CTL0802 (Rosuvastatin) — full drug profile →
- CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin) — full drug profile →
Conditions studied
- Health, Subjective — all drugs for Health, Subjective →
Sponsor
Celltrion — full company profile →
Who can join
Adults 19 to 50, any sex, with Health, Subjective. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult 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 NCT05002244
- 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 NCT05002244 (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: 23 December 2021
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/NCT05002244.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing