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A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects

NCT06332053 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-27

No results posted yet for this study

Summary

This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin).

Conditions

  • Healthy Subjects

Interventions

DRUG

SY-5007

SY-5007 80 mg, Tablets, 2 discrete single doses at Day 1 and Day 11

DRUG

Itraconazole

Itraconazole 200 mg, Capsules, Day 8-Day 18

DRUG

SY-5007

SY-5007 160 mg, Tablets, 2 discrete single doses at Day 1 and Day 16

DRUG

Rifampin

Rifampin 600 mg, Capsules, Day 8-Day 21

Sponsors & Collaborators

  • Shouyao Holdings (Beijing) Co. LTD

    lead OTHER

Principal Investigators

  • Yinghui Sun · Shouyao Holdings (Beijing) Co. LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06332053 on ClinicalTrials.gov