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NCT02491450
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)
Phase 1 trial testing Heterosofir in Healthy in 24 participants. Completed in 1 February 2015.
1 February 2015
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 February 2015 |
| Primary completion | 1 February 2015 |
| Estimated completion | 1 February 2015 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Heterosofir — full drug profile →
- Sovaldi — 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 72 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected at 0,00( pre-dose), 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, 7.00, 9.00, 12.00, 24.00, 48.00 \& 72.00 hours post-dose
Sponsor's own description
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) 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:
- PubMed search for NCT02491450
- 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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- 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 NCT02491450 (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: 2 July 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/NCT02491450.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing