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NCT04942652
Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers
Phase 1 trial testing Itraconazole 200 mg in Achlorhydria in 13 participants. Completed in 24 August 2021.
6 August 2021
Quick facts
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 13 July 2021 |
| Primary completion | 6 August 2021 |
| Estimated completion | 24 August 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Itraconazole 200 mg — full drug profile →
- Esomeprazole 40 mg — full drug profile →
Conditions studied
- Achlorhydria — all drugs for Achlorhydria →
Sponsor
Seoul National University Hospital
Who can join
Adults 19 to 50, any sex, with Achlorhydria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prediction of gastric pH-mediated drug exposure using physiologically-based pharmacokinetic modeling: A case study of itraconazole.
Yang E, Yu KS, Lee S. · · 2023 · cited 9× · PMID 36967484 · DOI 10.1002/psp4.12959
Verify or expand the search:
- PubMed search for NCT04942652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Seoul National University Hospital trials
Trials by the same sponsor.
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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 NCT04942652 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
- Last refreshed: 29 September 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/NCT04942652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing