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CLINICAL_TRIALS trial_result · 2026-03-05

Clinical Trial Update: 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 [Phase 2, Phase 3]

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Summary

A Phase 2/3 trial update comparing the PK and PD biosimilarity of Amphastar's insulin aspart biosimilar I004 to NovoLog after a single subcutaneous dose in heal…

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Diseases / indications

Drugs mentioned

  • I004 insulin aspart biosimilar (insulin aspart)
  • NovoLog (insulin aspart)

Snippet

Sponsor: Amphastar Pharmaceuticals, Inc. | Conditions: Pharmacokinetics, Pharmacodynamics | Phase 2, Phase 3 | Status: COMPLETED | Results posted: 2026-03-05