NCT05038969 is a Phase 1 clinical trial of Stomopral in Healthy, sponsored by Genuine Research Center, Egypt.

Who is sponsoring NCT05038969?

NCT05038969 is sponsored by Genuine Research Center, Egypt.

What drugs are being tested in NCT05038969?

Interventions in NCT05038969: Stomopral, Nexium.

Is NCT05038969 still recruiting?

NCT05038969 is currently completed. Last updated 9 September 2021.

Last reviewed 2021-09-09 · How we verify

NCT05038969

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France)

Completed Phase 1 Last updated 9 September 2021

What this trial tests

Phase 1 trial testing Stomopral in Healthy in 30 participants. Completed in 28 May 2021.

Timeline

18 March 2021

Primary endpoint
1 April 2021

28 May 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	30
Start date	18 March 2021
Primary completion	1 April 2021
Estimated completion	28 May 2021
Sites	1 location across Egypt

Drugs / interventions tested

Stomopral — full drug profile →
Nexium (esomeprazole) — 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

Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) in Healthy Human Volunteers Under Fasting Condition.

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:

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Other Genuine Research Center, Egypt trials

Trials by the same sponsor.

NCT05876585 — Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard o · Phase 3 · not yet recruiting
NCT05880056 — Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian P · Phase 4 · recruiting
NCT05798715 — Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 m · Phase 1 · completed
NCT05855187 — Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Vers · Phase 1 · completed
NCT05804721 — Bioequivalence Study of Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets (Man. by: P&C Labs (Pellets & CR Pro · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05038969 (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: 9 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/NCT05038969.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing