Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
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Phase
Phase 2/3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
62actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-06 | actual | When the study began enrolling |
| Primary completion | 2026-06-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-25 | actual | The whole study's end, after follow-up |
| First posted | 2026-04-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pharmacokinetics
- Pharmacodynamics
- Insulin Aspart
Interventions
- Drug: I004 — also filed as Insulin Aspart, a rapid-acting human insulin analogue
- Drug: NovoLog — also filed as Insulin Aspart, a rapid-acting human insulin analogue
Primary outcomes
what the primary-completion date above is the date OFMaximum Serum Insulin Aspart Concentration, CIAmax
measured Baseline (Time 0) to 12 hours post-dose
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h)
measured 0 to 12 hours post-dose
Maximum Glucose Infusion Rate, Gmax
measured From drug administration to 12 hours post-dose
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)
measured From drug administration to 12 hours post-dose
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