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NCT03062423
Comparative Open-label,Randomized, Fed, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Phase 1 trial testing Sofodelevier in Healthy in 36 participants. Completed in 1 November 2016.
1 October 2016
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 | 36 |
| Start date | 1 October 2016 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 November 2016 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Sofodelevier — full drug profile →
- Sovaldi (fist dose) — full drug profile →
- Sovaldi (second dose) — 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: Up to 7 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected at 0, 00, 0,166, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours
Sponsor's own description
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier 400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
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 NCT03062423
- 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.
- 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)
- Trial protocol + status: ClinicalTrials.gov NCT03062423 (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: 30 July 2019
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/NCT03062423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing