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NCT05235217
Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition
Phase 1 trial testing Test product (T) 40 mg Hard Gelatin Capsules in Bioequivalence in 32 participants. Completed in 18 June 2021.
18 June 2021
Quick facts
| Lead sponsor | Future University in Egypt |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 32 |
| Start date | 3 June 2021 |
| Primary completion | 18 June 2021 |
| Estimated completion | 18 June 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Test product (T) 40 mg Hard Gelatin Capsules — full drug profile →
- Reference product (R) 40 mg Hard Gelatin Capsules — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Future University in Egypt
Who can join
Adults 18 to 44, male only, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.
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 NCT05235217
- 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 NCT05235217 (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 Future University in Egypt
- Last refreshed: 11 February 2022
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/NCT05235217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing