Trial Profile

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: A Single-Center Randomized, Double-blinded, Two-Treatment, Two-period, Two-sequence Crossover, Hyperinsulinemia-Euglycemic Clamp

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 25 Jul 2023

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At a glance

Drugs Insulin-aspart-biosimilar-Amphastar-Pharmaceutical (Primary) ; Insulin aspart
Indications Diabetes mellitus
Focus Pharmacokinetics
Sponsors Amphastar Pharmaceuticals

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