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The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SH-1028

NCT04808648 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-22

No results posted yet for this study

Summary

This is a phase I study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.

Conditions

  • Healthy Male Volunteers

Interventions

DRUG

SH-1028

tablet, oral, 200 mg once daily for day 1 and day 12

DRUG

Itraconazole

capsule, oral, 200 mg twice daily for day 8 to day 14

DRUG

Rifampicin

capsule, oral, 600 mg once daily for day 8 to day 16

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2021-06-10
Completion
2021-06-30

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 NCT04808648 on ClinicalTrials.gov