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Study on Hydronidone Capsule BE

NCT04125056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-14

No results posted yet for this study

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

DRUG

Hydronidone Capsule(Specification: 30 mg / grain）

Test group

DRUG

Hydronidone Capsule(Specification: 15 mg / grain）

Control group

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125056 on ClinicalTrials.gov