NCT04125056

Study on Hydronidone Capsule BE

Bioequivalence Test of Hydronidone Capsules in the Hollow Abdominal State of Chinese Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Hydronidone Capsule(Specification: 30 mg / grain）	Test group
DRUG	Hydronidone Capsule(Specification: 15 mg / grain）	Control group

Timeline

• Start date: 2019-01-16
• Primary completion: 2019-01-23
• Completion: 2019-03-04
• First posted: 2019-10-14
• Last updated: 2019-10-14

Locations

1 site across 1 country: China