Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Hydronidone
• Interventions: Drug: Hydronidone capsules& Entecavir capsules

• Registration Number: NCT04124081
• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Brief Summary

This study, by comparing the Hydronidone capsules and entecavir capsule in a single dose and steady-state dosing state of both the level of blood drug concentration, assess Hydronidone capsules and entecavir capsule for interaction。

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-05-15
• Primary Completion: 2019-06-15
• Study Completion: 2019-08-13
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug group	Hydronidone capsules& Entecavir capsules	-

Primary Outcome Measures

Name	Time	Method
Plasma drug concentration	up to 12 weeks	Compare the difference in plasma drug concentration between single drug and two drug combinations

Trial Locations

Locations (1)

Ethics committee of drug clinical trials of huazhong university of science and technology; 🇨🇳 Wuhan, Hubei, China