Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04808648
Study type Interventional
Source Nanjing Sanhome Pharmaceutical, Co., Ltd.
Contact Huan Zhou, Ph D
Phone 13665527160
Email zhouhuan@bbmc.edu.cn
Status Not yet recruiting
Phase Phase 1
Start date April 6, 2021
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT05523687 - AME Study of [14C]-PC14586 in Healthy Male Participants Phase 1
Completed NCT02250976 - The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Phase 1
Completed NCT01948011 - Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules Phase 1
Completed NCT04086719 - An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition. Phase 1
Completed NCT03686501 - D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562 Early Phase 1
Terminated NCT01965301 - First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 Phase 1
Completed NCT01005160 - Drug Interaction Between CKD-501 and Metformin Phase 1
Completed NCT04534582 - Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects Phase 1
Recruiting NCT06159101 - A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects Phase 1
Completed NCT01549743 - The Pharmacokinetic Interaction Between Celecoxib and Rebamipide Phase 1
Completed NCT03532854 - Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802 Phase 1
Recruiting NCT03530228 - A Phase 1 Study of Tegoprazan on Healthy Male Volunteers Phase 1
Completed NCT01356043 - CKD-828 Drug Interaction Study (S-amlodipine) Phase 1
Completed NCT04810533 - The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers Phase 1
Completed NCT03089112 - Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501 Phase 1
Completed NCT01939639 - The Influence of Oxytocin on the Processing of Social Contact Phase 1
Completed NCT01342055 - Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers Phase 1
Terminated NCT03863587 - Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects Phase 1
Completed NCT01606462 - Oxytocin and Social Cognition Phase 1
Completed NCT01382017 - Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study N/A