A Pharmacokinetic Drug–Drug Interactions Study between Entecavir and Hydronidone, a Potential Novel Antifibrotic Small Molecule, in Healthy Male Volunteers

Autor: Rui, Zhang, Peixia, Li, Pengpeng, Guo, Jinping, Zhou, Jing, Wan, Chunxiao, Yang, Jiali, Zhou, Yani, Liu, Shaojun, Shi
Rok vydání: 2022
Předmět:
Zdroj: Advances in Therapy. 40:658-670
ISSN: 1865-8652
0741-238X
Popis: Hepatic fibrosis is an inevitable process of hepatic sclerosis, malignancy, and insufficiency, and hydronidone is an innovative antifibrosis drug. This study focus on the pharmacokinetic interaction of hydronidone and entecavir in healthy Chinese male subjects.An open-label, three-period, multiple-dosage, self-controlled clinical trial was executed in 12 healthy male subjects. In period 1, the subjects took hydronidone 60 mg, q8h, for 7 days. In period 2, they were given entecavir 0.5 mg once daily for 9 days. Then, hydronidone and entecavir were given in combination for 6 days (days 20-26). Blood samples were taken up to 24 h post-dosing, while pre-dose blood samples were drawn on days 7, 19, and 26.The area under the curve (AUC)There was no drug-drug interaction between hydronidone and entecavir in healthy male volunteers. However, multiple doses of hydronidone have a risk with increasing exposure to entecavir in vivo, which needs to be further clarified.ChiCTR2200059683 (retrospectively registered).
Databáze: OpenAIRE
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