drugset / Trial / NCT04125056
Study on Hydronidone Capsule BE
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydronidone | Small molecule | 15 mg | — |
| Subject | Hydronidone | Small molecule | 30 mg | — |
Indications
No indication recorded.