This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.
This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
Research Site
Hong Kong, Hong Kong
Mean change from baseline to ZS treatment period in urine potassium excretion.
The 48- hour urine potassium excretion on Study Days 3 and 4 (baseline) will be compared with 48-hour urine potassium excretion on Study Days 7 and 8 (on study drug).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Mean change from baseline to ZS treatment period in urine sodium excretion.
The 48- hour urine sodium excretion on Study Days 3 and 4 (baseline) will be compared with 48- hour urine sodium excretion on Study Days 7 and 8 (on study drug).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Mean change from baseline to ZS treatment period in serum potassium (S-K).
Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
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