Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05943977
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2023-03-22
Brief Title:
A Bioequivalence and Efficacy Study of MB-102 Relmapirazin in Chinese Participants
Sponsor:
Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd
Organization:
Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part I bioequivalence will evaluate the bioequivalence of the Oversea Manufactured Sample used in the MediBeacon Phase 3 Study 100-103 NCT05425719 and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 Relmapirazin in healthy Chinese adults Part II efficacy will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 Relmapirazin for Evaluation of Kidney Function in Chinese participants
Detailed Description:
Part I bioequivalence will be conducted as an open-label 2-period 2-treatment crossover study with 24 subjects expected to enroll Blood and urine samples will be collected Part II efficacy will enroll up to 100 subjects divided into 2 strata 11 in accordance with screening eGFR measured by the CKD-EPI equation Blood samples will be collected at predefined time points and the MediBeacon Transdermal GFR Measurement System will be used to collect fluorescent measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20230300 | REGISTRY | wwwchinadrugtrialsorgcn | None |