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NCT04291846
A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects
Phase 1 trial testing SHR1459 fasted in P1, high-fat diet in P2 in Healthy Adult Subjects in 28 participants. Completed in 29 June 2020.
3 June 2020
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 28 |
| Start date | 24 May 2020 |
| Primary completion | 3 June 2020 |
| Estimated completion | 29 June 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR1459 fasted in P1, high-fat diet in P2 — full drug profile →
- SHR1459 high-fat diet in P1, fasted in P2 — full drug profile →
Conditions studied
- Healthy Adult Subjects — all drugs for Healthy Adult Subjects →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Healthy Adult Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
Verify or expand the search:
- PubMed search for NCT04291846
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Adult Subjects
Currently open trials in the same condition.
- NCT06635226 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects · Phase 1 · recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · 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 NCT04291846 (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 Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 27 July 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/NCT04291846.
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