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A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects - Trial NCT06332053

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.

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NCT06332053
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06332053
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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

Study Focus

Healthy Subjects

SY-5007

Interventional

drug

Sponsor & Location

Shouyao Holdings (Beijing) Co. LTD

Chengdu, China

Timeline & Enrollment

Phase 1

Apr 01, 2024

Jun 01, 2024

28 participants

Primary Outcome

Cmax for SY-5007,Tmax for SY-5007,AUC0-t for SY-5007,AUC0-โˆž for SY-5007,tยฝ 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 examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06332053

Non-Device Trial