Clinical Trials Logo
  1. Home
  2. Healthy Male Volunteers
  3. NCT05475834

Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

Healthy Male Volunteers Clinical Trial

Official title:
A Phase I Study to Investigate The Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

Clinical Trial Summary

This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.

Clinical Trial Description

This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of SIM0417 following a single oral administration of SIM0417 combination with ritonavir in healthy Chinese adult male subjects. This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417 administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration. SIM0417 is administered after meals, ritonavir is administered either in fasting condition or after meals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05475834
Study type Interventional
Source Jiangsu Simcere Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 21, 2022
Completion date August 7, 2022
View Details
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 NCT01356017 - CKD-828 Drug Interaction Study (Telmisartan) Phase 1
Completed NCT01606462 - Oxytocin and Social Cognition Phase 1