drugset / Trial / 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
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-08-22
- Primary completion
- 2023-01-29
- Completion
- 2023-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | I004 | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
Indications
No indication recorded.