The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokinetics.
Age range
18 Years – 45 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs)
Timeframe: Up to 8 days after the first dosing.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Single Ascending Dose Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Single Ascending Dose Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Single Ascending Dose Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Single Ascending Dose Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Terminal Elimination Half-life (T1/2) in Single Ascending Dose Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Food Effect Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Food Effect Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Food Effect Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Food Effect Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration
Terminal Elimination Half-life (T1/2) in Food Effect Study
Timeframe: Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration