A Phase 1 interventional study of GST-HG171/ritonavir and ritonavir in COVID-19 Respiratory Infection, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment
A single-center, randomized, open, single-dose, two-cycle, two-sequence, cross-over study was conducted to evaluate the effect of food on the pharmacokinetic characteristics of GST-HG171 in combination with Ritonavir.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's planned enrollment of 18 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Fujian Akeylink Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.
Drug: GST-HG171/ritonavir · Drug: ritonavir
Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.
Drug: GST-HG171/ritonavir · Drug: ritonavir
Single oral dose of GST-HG171 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1
Single oral dose of ritonavir 100 mg at -12 hours prior to GST-HG171/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours and 24 hours after GST-HG171/ritonavir dosing.
Cmax
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
Time frame: Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
AUCinf
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171
Time frame: Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
AUClast
Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171
Time frame: Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
urine
Total recovery of GST-HG171 -related substances in urine
Time frame: 120 hours from GST-HG171 administration
feces
Total recovery of GST-HG171 -related substances in feces
Time frame: 120 hours from GST-HG171 administration
Plan to share: No
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This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Fujian Akeylink Biotechnology Co., Ltd.