This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of TNP-2092 Capsules in eradicating Helicobacter pylori.
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Safety of TNP-2092 by Assessment of the Number of Adverse Events (AEs)
Timeframe: Day 1 to Day 49
Area Under the Plasma Concentration Versus Time Curve Over a Dosing Interval (AUC0-tau) on Day 1
Timeframe: Day 1:Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 on Day 1
Timeframe: Day 1:Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Time to Reach the Maximum Observed Plasma Concentration (Tmax) on Day 1
Timeframe: Day 1:Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) on Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Area Under the Plasma Concentration Versus Time Curve From the First Administration to the Last Measurable Plasma Concentration (AUC0-last) on Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Area Under the Plasma Concentration Versus Time Curve Over a Dosing Interval (AUC0-tau) on Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 on Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Time to Reach the Maximum Observed Plasma Concentration (Tmax) Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Half Life (t1/2) of TNP-2092 on Day 15
Timeframe: Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Number of Participants With Negative Results of 14 Urea Breath Test (14C UBT) at 4 to 6 Weeks After Last Dose
Timeframe: Four to 6 weeks after the last dose of the study drugs.
Accumulation Index Rac (AUC) of TNP-2092
Timeframe: Day 1:Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration. Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Accumulation Index Rac(Cmax) of TNP-2092
Timeframe: Day 1:Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration. Day 15: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration