Abstract

The number of drug-drug interaction (DDI) clinical trials in China has increased rapidly in recent years. The aim of this study was to summarize and analyze DDI clinical trials in China over the past 10 years. We conducted a cross-sectional study of DDI clinical trials registered in the Chinese Center for Drug Evaluation (CDE) from September 6, 2013 to December 31, 2022. All related registration information disclosed on the CDE website were summarized and analyzed. Although the number of DDI clinical trials conducted before 2017 was relatively low, it increased markedly after 2017. The average duration of DDI clinical trials was 85.83 ± 100.99 days from 2013 to 2019 and 107.16 ± 98.57 days from 2020 to 2022. The duration of rifampicin use was 5–19 days, and the investigational drug was administered after 5–14 days of rifampicin use. Itraconazole was administered for 4–17 days, and the investigational drug was administered after 3–10 days of itraconazole use. Clinical trials of drug-drug interactions have recently increased due to the development of new drugs and the updated policies regulating drug registration and marketing. Although the designs of clinical trials comply with the new guidelines, the duration of the administration of interacting drugs still varies widely. Optimizing protocol designs can shorten the implementation period of clinical trials and reduce the costs of drug marketing.

By Jianxiong Zhang, Jingxuan Wu, Jiangshuo Li, Meixia Liu, Shaodan Liu, Ruirui He & Ruihua Dong