I004

DRUG2 trials

Sponsors

Amphastar Pharmaceuticals, Inc.

Conditions

Insulin AspartPharmacodynamicsPharmacokinetics

Phase 2

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

CompletedNCT05539872

Amphastar Pharmaceuticals, Inc.Pharmacodynamics, Pharmacokinetics

Start: 2022-08-22End: 2023-01-30Updated: 2026-03-05

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

RecruitingNCT07560150

Amphastar Pharmaceuticals, Inc.Insulin Aspart, Pharmacodynamics, Pharmacokinetics

Start: 2026-04-06End: 2026-06-01Target: 60Updated: 2026-04-30