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NCT06332053

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

A Randomized, Open-label, Two-period, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of SY-5007 Tablets in Healthy Subjects
Shouyao Holdings (Beijing) Co. LTD·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
SY-5007
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shouyao Holdings (Beijing) Co. LTD
Location
Chengdu, China
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Jun 01, 2024
Enrollment
28 participants
Primary outcome

Cmax for SY-5007,Tmax for SY-5007,AUC0-t for SY-5007,AUC0-∞ for SY-5007,t½ for SY-5007,CL/F for SY-5007,Vz/F for SY-5007

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).

ICD-10 classifications
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06332053
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06332053 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shouyao Holdings (Beijing) Co. LTD and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 28 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.