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Clinical trial

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

NCT05539872 is registered in ClinicalTrials.gov with Amphastar Pharmaceuticals, Inc. as lead sponsor.

NCT NCT05539872
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Phase
Phase 2/3
Overall status
Completed
Start date
August 22, 2022
Completion date
January 30, 2023
Enrollment
69 (actual)
Sites
1

Conditions

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

pharmacodynamics, pharmacokinetics