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NCT05539872 · ClinicalTrials.gov registry record · 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
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT05539872: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT05539872 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05539872, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Primary Outcome
Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart.
Interventions
- DRUG I004
- DRUG NovoLog
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2023-01-30 |
| Phase | Phase 2 |
What the finished NCT05539872 record still lists
NCT05539872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which I004 is the first listed.
NCT05539872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05539872 about?
NCT05539872 is a clinical study titled "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". This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
What is the current status of trial NCT05539872?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2022-08-22. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT05539872?
The interventions under investigation include: I004 (DRUG), NovoLog (DRUG).
Who is sponsoring clinical trial NCT05539872?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05539872's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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