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A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects

NCT03748745 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-08-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.

Conditions

  • Drug Interactions

Interventions

DRUG

SH229

tablet, oral, 600 mg once daily for day 1 to day 14

DRUG

SH229

tablet, oral, 600 mg once daily for day 8 to day 14

DRUG

Daclatasvir dihydrochloride

tablet, oral, 60 mg once daily for day 8 to day 14

DRUG

Daclatasvir dihydrochloride

tablet, oral, 60 mg once daily for day 1 to day 14

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · Phase I Clinical Trial Unit, The First Hospital of Jilin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2018-12-25
Completion
2018-12-25

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 NCT03748745 on ClinicalTrials.gov