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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: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study

NCT07560150 is registered in ClinicalTrials.gov with Amphastar Pharmaceuticals, Inc. as lead sponsor.

NCT NCT07560150
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Registry record

As filed in ClinicalTrials.gov.

Title
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: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Phase
Phase 2/3
Overall status
Completed
Start date
April 6, 2026
Completion date
June 25, 2026
Enrollment
62 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

insulin aspart, pharmacodynamics, pharmacokinetics