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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 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 69 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05539872
The ClinicalTrials.gov registry entry for NCT05539872 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 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.
NCT05539872 reports 0 study locations.
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.
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