Clinical Trial

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

Completed Phase 2/3
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Summary
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Protocol Amendment History 1 change
critical Trial completed 2026-07-23
Trial Details
NCT Number NCT07560150
Lead Sponsor Amphastar Pharmaceuticals, Inc.
Conditions Pharmacokinetics, Pharmacodynamics, Insulin Aspart
Enrollment 62 participants
Start Date 2026-04-06
Primary Completion 2026-06-22 (estimated)
Study Completion 2026-06-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-22