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NCT05135793
Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
Phase 1 trial testing Topoprazan in Healthy in 29 participants. Completed in 1 March 2021.
2 February 2021
Quick facts
| Lead sponsor | Genuine Research Center, Egypt |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 29 |
| Start date | 19 January 2021 |
| Primary completion | 2 February 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Topoprazan — full drug profile →
- Takecab — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Genuine Research Center, Egypt — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
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 NCT05135793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Genuine Research Center, Egypt 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 NCT05135793 (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 Genuine Research Center, Egypt
- Last refreshed: 26 November 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/NCT05135793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing