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NCT07560150 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07560150 is a Phase 2 study that is actively recruiting participants, run by Amphastar Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT07560150, a Phase 2 study, is actively recruiting participants, sponsored by Amphastar Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 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 pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Interventions
- DRUG I004
- DRUG NovoLog
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-04-06 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07560150
The ClinicalTrials.gov registry entry for NCT07560150 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which I004 is the first listed.
NCT07560150 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07560150 about?
NCT07560150 is a clinical study titled "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". 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 pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
What is the current status of trial NCT07560150?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-04-06. Estimated completion is 2026-06.
What interventions are being tested in trial NCT07560150?
The interventions under investigation include: I004 (DRUG), NovoLog (DRUG).
Who is sponsoring clinical trial NCT07560150?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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