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NCT03255993
The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People
Phase 1 trial testing SPH3127 50mg in Hypertension in 24 participants. Completed in 20 September 2018.
20 September 2018
Quick facts
| Lead sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 23 October 2017 |
| Primary completion | 20 September 2018 |
| Estimated completion | 20 September 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- SPH3127 50mg — full drug profile →
- SPH3127 100mg — full drug profile →
- Placebo matching to SPH3127 50mg — full drug profile →
- Placebo matching to SPH3127 100mg — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →
Who can join
18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial.
Jing S, Xu R, Yang K, Liu W, et al · · 2021 · cited 2× · PMID 33653620 · DOI 10.1016/j.clinthera.2021.01.025
Verify or expand the search:
- PubMed search for NCT03255993
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Shanghai Pharmaceuticals Holding Co., Ltd trials
Trials by the same sponsor.
- NCT06839131 — A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. · Phase 1 · recruiting
- NCT06487455 — A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors. · Phase 1 · recruiting
- NCT06434597 — A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patient · Phase 2 · recruiting
- NCT06483373 — A Clinical Study of SPH7854 Granules in Healthy Subjects. · EARLY_PHASE1 · recruiting
- NCT05046314 — A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma · Phase 2 · 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 NCT03255993 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Shanghai Pharmaceuticals Holding Co., Ltd
- Last refreshed: 15 November 2021
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/NCT03255993.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing