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

Phase 1 Not yet recruiting 10 enrolled Shanghai Jiao Tong University School of Medicine

RandomizedCrossoverOpen-labelTreatment

Summary

Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU

Timeline

Start: 2025-03-31
Primary completion: 2025-04-24
Completion: 2025-06-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin	Protein / enzyme biologic	5 iu	Oral
Subject	Insulin	Protein / enzyme biologic	32 mg	Oral

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

Summary

Timeline

Drugs

Indications