Clinical trials / NCT05539872
NCT05539872Phase 2, phase 3Completed

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar 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 completion2023-01-29Actual
Enrollment · participants69Actual
Source updated2026-03-05Last update listed in the registry record
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Primary outcomes · main study measures

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− Previous value

measure: Maximum Serum Insulin Aspart Concentration, CIAmax; measure: Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 12 hours post-dose, AUCIA(0-12h); measure: Maximum Serum Human Insulin Concentration, CHImax; measure: Area Under the Curve (AUC) of Human Insulin Serum Concentration from time 0 to 12 hours post-dose, AUCHI(0-12h); measure: Maximum Glucose Infusion Rate, Gmax; measure: Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 12 hours post-dose, AUCG(0-12h)

+ Updated value

measure: Maximum Serum Insulin Aspart Concentration, CIAmax; measure: Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h); measure: Maximum Glucose Infusion Rate, Gmax; measure: Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)

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