This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
Oral
The placebo for TNP-2198 active drug
The First Hospital of Jilin University
Changchun, Jilin, China
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Time frame: Day 1 to Day 4
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma PK parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Maximum Observed Plasma Concentration (Cmax) of TNP-2198
Plasma concentrations of TNP-2198 were measured by a specific and validated assay at specified time points
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
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