drugset / Trial / NCT04125056

Study on Hydronidone Capsule BE

NCT04125056

RandomizedCrossoverQuadruple-blindBasic science

Summary

The purpose of this study was to compare the hydronidone capsules (specification: 30 mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in the extent and rate of absorption of healthy male subjects in Fasting state in China. Through the main pharmacokinetic parameters and relative bioavailability, whether the two are bioequivalent, and provide a basis for the registration of the test preparation

Timeline

Start
2019-01-16
Primary completion
2019-01-23
Completion
2019-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydronidone Small molecule 15 mg
Subject Hydronidone Small molecule 30 mg

Indications

No indication recorded.