Status: Recruiting
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
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.
Participants needed: 60
Trial details
Phase: Phase 2, Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Amphastar Pharmaceuticals, Inc.Updated: Apr 30, 2026Locations: 1
Eligibility criteria
Upon review, agree to participate and sign informed consent. [+7]
History of diabetes mellitus. [+20]