drugset
drugset / Trial / NCT06519604

Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males

NCT06519604 ↗

Phase 1 Active not recruiting 20 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedCrossoverOpen-labelTreatment

Summary

Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU

Timeline

Start
2024-07-17
Primary completion
2024-09-13
Completion
2025-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic 5 iu Subcutaneous
Comparator Insulin Protein / enzyme biologic 8 mg Oral
Comparator Insulin Protein / enzyme biologic 16 mg Oral

Indications

diabetes mellitus