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Clinical trial

A Randomized, Open Label, 2-Period, Cross-over Study to Evaluate the Bioequivalence of the Oversea Manufactured Sample and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) (Part I), and an Efficacy Study to Assess the Performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese Normal and Renal Compromised Subjects (Part II)

NCT05943977 is registered in ClinicalTrials.gov with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. as lead sponsor.

NCT NCT05943977
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open Label, 2-Period, Cross-over Study to Evaluate the Bioequivalence of the Oversea Manufactured Sample and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) (Part I), and an Efficacy Study to Assess the Performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese Normal and Renal Compromised Subjects (Part II)
Lead sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Phase
Phase 3
Overall status
Completed
Start date
March 2, 2023
Completion date
November 30, 2023
Enrollment
121 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

kidney diseases, kidney failure, kidney injury