drugset / Trial / NCT05413863
Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects
Phase 1
Completed
78 enrolled
Biocon Limited
Profil Institut für Stoffwechselforschung GmbH · collab
RandomizedParallel-groupDouble-blindOther
Summary
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Timeline
- Start
- 2022-05-30
- Primary completion
- 2022-12-12
- Completion
- 2022-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biocon's Human Insulin R U-500 | Unknown | 0.3 iu/kg | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | 0.3 iu/kg | Subcutaneous |
Indications
No indication recorded.