Changeflow GovPing Pharma & Drug Safety Bioequivalence Study Chiglitazar Metformin T2DM
Routine Notice Added Final

Bioequivalence Study Chiglitazar Metformin T2DM

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Summary

The National Library of Medicine registered a new bioequivalence clinical trial on ClinicalTrials.gov. The study (NCT07519265) evaluates the bioequivalence of Chiglitazar and Metformin co-administration in patients with Type 2 Diabetes Mellitus (T2DM). The trial is listed as recruiting with an estimated enrollment of 36 participants at a single site in China.

What changed

ClinicalTrials.gov published a new trial registration for a bioequivalence study comparing Chiglitazar combined with Metformin against reference products in Type 2 Diabetes Mellitus patients. The study is listed as recruiting with 36 participants at one China site. Trial registration on ClinicalTrials.gov is required under FDAAA 801 for applicable clinical trials.

Clinical investigators and sponsors should ensure trial registration is current and complete on ClinicalTrials.gov. FDAAA 801 requires registration and results reporting for applicable clinical trials of drugs and devices, with potential penalties for non-compliance.

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Archived snapshot

Apr 11, 2026

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Last updated

Classification

Agency
NLM
Published
November 1st, 2023
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07519265

Who this affects

Applies to
Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Bioequivalence research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals

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