Safety analysis on bioequivalence studies of orally inhaled drug products in healthy Chinese subjects
10.12092/j.issn.1009-2501.2023.10.006
- Author:
Min LIU
1
;
Ye ZHANG
1
;
Kai HUANG
1
;
Xiang KONG
2
;
Yifei GU
3
;
Xuemei XIANG
3
Author Information
1. Drug Clinical Trial Institution, Affiliated Wuxi People's Hospital of Nanjing Medical University
2. Department of Endocrinology, The First Aflliated Hospital of Wannan Medical College, Yijishan Hospital
3. Wuxi Clinical Medical School of Nanjing Medical University
- Publication Type:Journal Article
- Keywords:
bioequivalence study;
healthy subjects;
orally inhaled drug products;
safety analysis
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2023;28(10):1131-1138
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To investigate the safety of bioequivalence (BE) studies of orally inhaled drug products (OIDPs) conducted by Phase I clinical Research Center of our hospital. METHODS: The safety data were collected from 482 healthy subjects enrolled in 20 OIDPs BE studies in Wuxi People's hospital from 2017 to 2022. The difference of adverse events (AEs) between test preparation and reference preparation were compared, as well as the influence of gender, age, mechanism of drug action and device type on AE were analyzed. RESULTS: A total of 102 cases of AEs were occurred in 77 subjects (16.0%, 77/482), 87 cases of AEs were related to experimental drugs, all AEs were mild or moderate, and no serious adverse events occurred. There was no difference in the incidence of AE between test preparation and reference preparation. In addition, gender, age, mechanism of drug action and device type had no significant effects on AEs. CONCLUSION: In 20 bioequivalence studies of OIDPs, OIDPs were safe and well tolerated in healthy subjects after dosing, and safety features of generic OIDPs and original drug were basically similar.
