Multiple clinical trials spanning Phase 1 and unclassified developmental phases evaluate pharmacokinetic responses and dose-dependent management strategies in healthy volunteers and patients with type 2 diabetes. Sponsored by entities including Baxter Healthcare Corporation and the Hospital de Clinicas de Porto Alegre, these studies maintain recruitment statuses ranging from completed to unknown. Together, these records reflect early-stage clinical evaluations across healthy populations and metabolic disease contexts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05309304 | COMPLETED | Healthy |
Baxter Healthcare Corporation |
2022-02-14 | PHASE1 |
| NCT03423108 | UNKNOWN | Type2 Diabetes |
Hospital de Clinicas de Porto Alegre |
2018-09-10 |
(data from https://clinicaltrials.gov, updated on 2022-10-12)
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G150
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Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.