NCT07560150Phase 2, phase 3Completed

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

Study sponsor: Amphastar Pharmaceuticals, Inc. · AMPH

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-06-22Actual

Enrollment · participants62Actual

Source updated2026-07-22Last update listed in the registry record

Version history

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Posted 2026-07-22 · 5 fields changed

Participant count type

Recorded edit

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Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit

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count: 60; type: ESTIMATED

+ Updated value

count: 62; type: ACTUAL

Completion date type

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− Previous value

Estimated

+ Updated value

Actual

Primary completion date

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− Previous value

2026-06

+ Updated value

2026-06-22

Recruitment status

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Recruiting

+ Updated value

Completed

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Study details

Conditions studied

Pharmacokinetics; Pharmacodynamics; Insulin Aspart

Treatments or interventions studied

I004DrugAlso known as Insulin Aspart, a rapid-acting human insulin analogue
NovoLogDrugAlso known as Insulin Aspart, a rapid-acting human insulin analogue

Primary outcomes · main study measures

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measure: Maximum Serum Insulin Aspart Concentration, CIAmax; description: Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart; timeFrame: Baseline (Time 0) to 12 hours post-dose; measure: Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h); description: Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCIA(0-12h)) is reported.; timeFrame: 0 to 12 hours post-dose; measure: Maximum Glucose Infusion Rate, Gmax; description: Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response.; timeFrame: From drug administration to 12 hours post-dose; measure: Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h); description: Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg.; timeFrame: From drug administration to 12 hours post-dose

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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