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NCT05940883
A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects
Phase 1 trial testing Y-2 Sublingual Tablet in Healthy in 36 participants. Completed in 5 December 2023.
21 November 2023
Quick facts
| Lead sponsor | Simcere Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 6 September 2023 |
| Primary completion | 21 November 2023 |
| Estimated completion | 5 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Y-2 Sublingual Tablet — full drug profile →
- Y-2 Sublingual Tablet — full drug profile →
- Y-2 Sublingual Tablet — full drug profile →
- Y-2 Sublingual Tablet — full drug profile →
- Y-2 Sublingual Tablet — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Simcere Pharmaceutical Co., Ltd — 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
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.
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 NCT05940883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Simcere Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07510529 — A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for · Phase 1 · not yet recruiting
- NCT07393451 — A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis · Phase 2 · not yet recruiting
- NCT07402512 — A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children · Phase 3 · recruiting
- NCT06701149 — A Comparative Study of the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China · Phase 1 · completed
- NCT06477835 — A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic D · Phase 3 · 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 NCT05940883 (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 Simcere Pharmaceutical Co., Ltd
- Last refreshed: 12 December 2023
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/NCT05940883.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing