Lakhasly

maximum plasma concentration (max); time to reach Cmax (tmax); last measurable plasma concentration (Clast); area under the plasma concentration-time curve (AUC) from time zero to time of last measurable plasma concentration (AUClast), calculated according to the trapezoidal rule; AUC from time zero to infinity (AUC.), calculated using the equation: AUC.The term AE also applied to laboratory findings or results of other diagnostic procedures that were considered to be clinically relevant (e.g., required unscheduled diagnostic procedures or treatment measures or withdrawal from the study), unless directly related with the underlying disease of the participant (i.e., severe renal impairment).An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory find-ing), symptom or disease, temporally associated with the use of the medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used.QTc intervals were calculated using Fridericia's (QTcF) and Bazett's (QTcB) correction formulas [23).Vital signs (temperature, respiratory rate, supine/standing pulse rate, systolic and diastolic blood pressure, and bodyweight) were recorded daily.Routine hematology, biochemistry, and urinalysis were conducted at screening, pre-dose, and 72 h post-dose.

maximum plasma concentration (max); time to reach Cmax (tmax); last measurable plasma concentration (Clast); area under the plasma concentration-time curve (AUC) from time zero to time of last measurable plasma concentration (AUClast), calculated according to the trapezoidal rule;
AUC from time zero to infinity (AUC.), calculated using
the equation: AUC. = AUClast + Clast/ke, where ke is the
elimination rate constant from the central compartment; terminal disposition rate constant (Qz), calculated using linear regression on the terminal portion of the In-con-centration versus time curve; terminal elimination half-life (t%), calculated as 0.693/Nz; cumulative amount of unchanged drug excreted in urine (Ae), calculated as total amount of bilastine excreted unchanged in the urine over the entire period of sample collection; apparent total body clearance from plasma after oral administration (CLp/F, where F indicates bioavailability), calculated as dose/ AUC; renal clearance (CLR), calculated as Ae/AUC over a defined period of time; apparent volume of distribution during terminal phase after non-intravenous administration (V,/F), calculated as (CL,/F)/ke.
2.3 Safety Evaluations
Physical examinations were conducted on admission and at the end of the study. Vital signs (temperature, respiratory rate, supine/standing pulse rate, systolic and diastolic blood pressure, and bodyweight) were recorded daily. Twelve-lead ECG recordings were made pre-dose, and 1 and 24 h post-dose. Heart rate, PR interval, QRS interval, and QT interval were measured. QTc intervals were calculated using Fridericia's (QTcF) and Bazett's (QTcB) correction formulas [23).
Routine hematology, biochemistry, and urinalysis were conducted at screening, pre-dose, and 72 h post-dose.
AEs were collected for the duration of participation of the subject in the study and followed until satisfactory resolution. Information concerning AEs was solicited by the investigator by questioning subjects about any changes in their health condition, and as spontaneously reported by the subject. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory find-ing), symptom or disease, temporally associated with the use of the medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. The term AE also applied to laboratory findings or results of other diagnostic procedures that were considered to be clinically relevant (e.g., required unscheduled diagnostic procedures or treatment measures or withdrawal from the study), unless directly related with the underlying disease of the participant (i.e., severe renal impairment).