Comparative bioequivalence study of sodium zirconium cyclosilicate (SZC-9) in the forms of 5 and 10 g sachets vs brand medicine (Lokelma made by AztraZeneca)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130313012810N11

Enrollment

Registered

2023-07-15

Start date

2024-08-31

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperkalaemia. Hyperkalaemia

Interventions

Intervention 1: Intervention group 1: Candidates will receive 10 grams of powder (sachet) of the test drug and blood will be taken 48 hours after receiving the drug. Intervention 2: Intervention group

Eligibility

Sex/Gender

All

Age

22 Years to 75 Years

Inclusion criteria

Inclusion criteria: patients with hyperkalemia Volunteers aged 22-75 years male and female

Exclusion criteria

Exclusion criteria: History of diseases affecting the digestive system Taking any medication at least 1 week before the start of the study

Design outcomes

Primary

Measure	Time frame
Plasma concentration of potassium. Timepoint: Measurement of blood potassium at the beginning of the study (before the start of the intervention), 2, 6, 12, 24, 36, and 48 hours after receiving the drug by the patients. Method of measurement: Biorexfars potassium kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Hamishehkar

Tabriz University of Medical Sciences

hamishehkar.hamed@gmail.com+98 41 3336 3181

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026