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 NCT06124573
Ignite Creation Date: 2024-05-06 @ 7:46 PM
Last Modification Date: 2024-10-26 @ 3:13 PM
Study NCT ID: NCT06124573
Protocol Section: NCT06124573
Start Identification Module Data
Expand Identification Module Data
Brief Title: Bioequivalence Study of Sitagliptin Hydrochloride Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg 1000 mg FDC in Healthy Adult Male and Female Subjects Under Fed Conditions
Official Title: An Oral Single-dose Randomized Balanced Open-label Two-sequence Two-treatment Two-period Crossover Bioequivalence Study of Sitagliptin Hydrochloride Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg 1000 mg FDC of Galenicum Health SLU Spain With That of JANUMET XR Sitagliptin Phosphate Metformin Hydrochloride Extended-release Coated Tablets 100 mg 1000 mg FDC of Merck Sharp Dohme Pharmaceuticals Ltd Brasil in Healthy Adult Male and Female Subjects Under Fed Conditions
Acronym: None
Organization: Galenicum Health
Organization Class: INDUSTRY
Organization Study ID: ASCJMAR-220011
Start Status Module Data
Status Verified Date: 2023-11
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: Galenicum Health
Lead Sponsor Class: INDUSTRY
Lead Sponsor: Galenicum Health
Start Oversight Module Data
Description Module:
Study Last Update Post Date Type(Status Module):
Attachment: Upload