A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Study identifier:D9483C00001
ClinicalTrials.gov identifier:NCT03283267
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Medical condition
Hyperkalemia
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Sodium Zirconium Cyclosilicate (ZS)
Sex
All
Actual Enrollment
22
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 24 Oct 2017
Primary Completion Date: 23 Nov 2017
Study Completion Date: 23 Nov 2017
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZS 5g, qd Subjects randomized to this arm will receive ZS 5 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet. | Drug: Sodium Zirconium Cyclosilicate (ZS) Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration. |
| Experimental: ZS 10g, qd Subjects randomized to this arm will receive ZS 10 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet. | Drug: Sodium Zirconium Cyclosilicate (ZS) Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration. |
