Viewing Protocol Section

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Viewing Protocol Section

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Clinical Trials

To give you an idea of how we make custom software. We have taken all of the Clinical Trials Information from our Federal Government(https://clinicaltrials.gov/).

The JSON File Structure of the files is as follows: Full Study -> Study => Sections => Modules. You are currently viewing a Protocol Section and its Modules.

We give the table structure here to give you an idea of what you are looking at. We put the explanation to the left and the data to the right.

A Protocol Section has the following Modules.

1. Identification Module

2. Status Module

3. Sponsor Collaborators Module

4. Oversight Module

5. Description Module

6. Conditions Module

7. Design Module

8. Arms Interventions Module

9. Outcomes Module

10. Eligibility Module

11. Contacts Locations Module

12. References Module

13. IPD Sharing Statement Module

Viewing Protocol Section

Study NCT04601389
Ignite Creation Date: 2024-05-06 @ 3:21 PM
Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04601389
Protocol Section: NCT04601389
Start Identification Module Data
Expand Identification Module Data
Brief Title: Study of Pharmacokinetics Pharmacodynamics and Safety Assessment of GNR-044 JSC GENERIUM Russia and Xolair
Official Title: An Open-label Randomized in Parallel Groups Comparative Study of Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of Omalizumab JSC GENERIUM Russia and Xolair Novartis Pharma AG Switzerland After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg
Acronym: NAP
Organization: AO GENERIUM
Organization Class: INDUSTRY
Organization Study ID: OMA-HVL-I
Secondary IDs
Secondary ID Type Domain Link
88 effdata 16 Feb 2017 REGISTRY Ministry of Health of Russia approval number None
Start Status Module Data
Status Verified Date: 2020-10
Overall Status: COMPLETED
Study First Submit Date:
Study First Submit QC Date:
Last Update Submit Date:
Status:
Start Sponsor Collaborators Module Data
Investigator:
Lead Sponsor: AO GENERIUM
Lead Sponsor Class: INDUSTRY
Lead Sponsor: AO GENERIUM
Start Oversight Module Data
Description Module:
Study Last Update Post Date Type(Status Module):
Attachment: Upload