AMPH

Amphastar Pharmaceuticals, Inc.

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2Trials in this database

6Recorded changes · last 12 months

Partial coverageOnly the trials and history collected so far

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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Included trials

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Trial	Sponsor	Phase	Status	Primary completion
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 VolunteersNCT05539872	AMPH	Phase 2, Phase 3	Completed	2023-01-29Actual
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 VolunteersNCT07560150	AMPH	Phase 2, Phase 3	Completed	2026-06-22Actual

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

AMPHCompletedPrimary completion: 2023-01-29 · Actual

Trial details

Registry ID: NCT05539872
Phase: Phase 2, Phase 3

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

AMPHCompletedPrimary completion: 2026-06-22 · Actual

Trial details

Registry ID: NCT07560150
Phase: Phase 2, Phase 3

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Recruiting

+ Updated value

Completed

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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

NCT05539872 · Amphastar Pharmaceuticals, Inc.

Posted 2026-02-10 · 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Maximum Serum Insulin Aspart Concentration, CIAmax; measure: Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 12 hours post-dose, AUCIA(0-12h); measure: Maximum Serum Human Insulin Concentration, CHImax; measure: Area Under the Curve (AUC) of Human Insulin Serum Concentration from time 0 to 12 hours post-dose, AUCHI(0-12h); measure: Maximum Glucose Infusion Rate, Gmax; measure: Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 12 hours post-dose, AUCG(0-12h)

+ Updated value

measure: Maximum Serum Insulin Aspart Concentration, CIAmax; measure: Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h); measure: Maximum Glucose Infusion Rate, Gmax; measure: Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)

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