# 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** · PHASE2,PHASE3 · COMPLETED · sponsor: **Amphastar Pharmaceuticals, Inc.** · enrollment: 69 (actual)

## Conditions studied

- Pharmacokinetics
- Pharmacodynamics

## Interventions

- **DRUG:** I004
- **DRUG:** NovoLog

## Key facts

- **NCT ID:** NCT05539872
- **Lead sponsor:** Amphastar Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-08-22
- **Primary completion:** 2023-01-29
- **Final completion:** 2023-01-30
- **Target enrollment:** 69 (ACTUAL)
- **Last updated:** 2026-03-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05539872

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05539872, "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". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT05539872. Licensed CC0.

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