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NCT03495206
Sublingual Y-2(Edaravone And Borneol) Tablet For Acute Ischemic And Hemorrhagic Patients-the SALVAGE Trial
Phase 1 trial testing Y-2(Edaravone And Borneol) Sublingual Tablet in Stroke, Acute in 24 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | Yantai YenePharma Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 25 October 2018 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Y-2(Edaravone And Borneol) Sublingual Tablet — full drug profile →
Conditions studied
- Stroke, Acute — all drugs for Stroke, Acute →
- Intracranial Hemorrhages — all drugs for Intracranial Hemorrhages →
Sponsor
Yantai YenePharma Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Stroke, Acute or Intracranial Hemorrhages. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: 0 hours to 36 hours
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment
Sponsor's own description
The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Neuroprotective Phytochemicals in Experimental Ischemic Stroke: Mechanisms and Potential Clinical Applications.
Xu H, Wang E, Chen F, Xiao J, et al · · 2021 · cited 75× · PMID 34007405 · DOI 10.1155/2021/6687386 -
A Review on Natural Antioxidants for Their Role in the Treatment of Parkinson's Disease.
Mittal P, Dhankhar S, Chauhan S, Garg N, et al · · 2023 · cited 40× · PMID 37513820 · DOI 10.3390/ph16070908 -
Edaravone Dexborneol mitigates pathology in animal and cell culture models of Alzheimer's disease by inhibiting neuroinflammation and neuronal necroptosis.
Xu C, Mei Y, Yang R, Luo Q, et al · · 2024 · cited 8× · PMID 38678262 · DOI 10.1186/s13578-024-01230-8
Verify or expand the search:
- PubMed search for NCT03495206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT03495206 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yantai YenePharma Co., Ltd.
- Last refreshed: 13 February 2020
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/NCT03495206.
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