NCT04808648

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

A Single-center, Open-label, Drug-drug Interaction Study of SH-1028 Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total of 40 evaluable healthy male subjects will be enrolled in this study.The subjects will be divided into two groups, A and B, with 20 people in each group. In the itraconazole study (Group A), patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally. In the rifampicin study (Group B), patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-06-10
• Completion: 2021-06-30
• First posted: 2021-03-22
• Last updated: 2021-03-22

Locations

1 site across 1 country: China