NCT05593562 is a Phase 1, PHASE2 clinical trial of SPH3127 in Primary Mild and Moderate Hypertension, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

Who is sponsoring NCT05593562?

NCT05593562 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

What drugs are being tested in NCT05593562?

Interventions in NCT05593562: SPH3127.

What condition does NCT05593562 study?

NCT05593562 studies Primary Mild and Moderate Hypertension.

Is NCT05593562 still recruiting?

NCT05593562 is currently completed. Last updated 7 December 2022.

Last reviewed 2022-12-07 · How we verify

NCT05593562

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on Human Mass Balance of SPH3127 Tablets

Completed Phase 1, PHASE2 Last updated 7 December 2022

What this trial tests

Phase 1, PHASE2 trial testing SPH3127 in Primary Mild and Moderate Hypertension in 6 participants. Completed in 24 October 2022.

Timeline

16 October 2022

Primary endpoint
24 October 2022

24 October 2022

Quick facts

Lead sponsor	Shanghai Pharmaceuticals Holding Co., Ltd
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	6
Start date	16 October 2022
Primary completion	24 October 2022
Estimated completion	24 October 2022
Sites	1 location across China

Drugs / interventions tested

SPH3127

Conditions studied

Primary Mild and Moderate Hypertension — all drugs for Primary Mild and Moderate Hypertension →

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →

Who can join

Adults 18 to 45, male only, with Primary Mild and Moderate Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of \[14C\] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of \[14C\]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of \[14C\] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.

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:

Other trials of SPH3127

Trials testing the same drug.

NCT05019742 — Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis · Phase 2 · terminated
NCT03128138 — Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers · Phase 1 · completed

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05593562 (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 Shanghai Pharmaceuticals Holding Co., Ltd
Last refreshed: 7 December 2022

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/NCT05593562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing