A Study Evaluating the Bioavailability of Oral Insulin (N11005)

Phase 1 Completed 12 enrolled Beijing Hospital

RandomizedCrossoverOpen-labelBasic science

Summary

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

Timeline

Start: 2019-12-10
Primary completion: 2020-08-14
Completion: 2020-08-14

Publications

Pan Q, Wang X, Li W, Chen X, Zhuang Y, Zhou Q, Huang Y, Zhou Y, Lan L, Wang Z, Wang W, Hong J, Hao WH, Yang YT, Guo L. Pharmacokinetics, pharmacodynamics, and safety of prandial oral insulin (N11005) in healthy subjects. Front Endocrinol (Lausanne). 2023 Jul 26;14:1172327. doi: 10.3389/fendo.2023.1172327. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Insulin	Protein / enzyme biologic	0.1 iu/kg	Other
Subject	N11005	Protein / enzyme biologic	300 iu	—

Indications

No indication recorded.