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NCT02479867
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)
Phase 1 trial testing Cefadroxil in Healthy in 24 participants. Completed in 1 April 2014.
1 March 2014
Quick facts
| Lead sponsor | Genuine Research Center, Egypt |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 24 |
| Start date | 1 March 2014 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 April 2014 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Cefadroxil (CEFADROXIL) — 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. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximal measured plasma concentration (Cmax)
Time frame: 12 hours
Serial blood samples for determination of study drug will be collected pre-dose and at 0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours.
Sponsor's own description
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira Pharm \&Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each to healthy adults 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 NCT02479867
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02479867 (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: 21 June 2015
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/NCT02479867.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing