To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period.
Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period.
Unnamed facility
Neu-Ulm, Bavaria, Germany
Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to the last data point greater than (\>) LLOQ (AUC\[0-tlast\]) after single dose.
Time frame: 0 hour (h) (pre-dose) to 72 h post-dose
Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
Maximum observed loratadine concentration in plasma, directly taken from analytical data.
Time frame: 0 h (pre-dose) to 72 h post-dose
Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine
Time to reach maximum loratadine concentration in plasma after its single oral dose, directly taken from analytical data.
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single Dose
Area under the concentration versus time curve from zero to infinity after single dose.
Time frame: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single Dose
Half-life associated with the terminal slope.
Time frame: 0 h (pre-dose) to 72 h post-dose
Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration
Total body clearance of loratadine calculated after extravascular application.
Time frame: 0 h (pre-dose) to 72 h post-dose
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Percentage of Area Under the Concentration Versus Time Curve (AUC) From the Last Calculated Data Point Greater Than Lower Limit of Quantification [LLOQ]) to Infinity (%AUC[tlast-∞]) After Single Oral Administration of Loratadine
Percentage of AUC from the last calculated data point \> LLOQ to infinity was measured.
Time frame: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose
Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points \> LLOQ.
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral Dose
Area under the concentration versus time curve from zero to 72 h after single dose.
Time frame: 0 h (pre-dose) to 72 h post-dose
Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Maximum observed desloratadine concentration in plasma, directly taken from analytical data.
Time frame: 0 h (pre-dose) to 72 h post-dose
Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of Loratadine
Time to reach maximum drug concentration in the measured matrix, directly observed from the analytical data.
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Desoratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to the last data point \> LLOQ (AUC\[0-tlast\]) after single dose.
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to 72 h after single dose. AUC and residual area were not evaluated because the concentration at 72 h was quantifiable in the majority of profiles.
Time frame: 0 h (pre-dose) to 72 h post-dose
Time of Last Concentration Above the Lower Limit Of Quantitation (LLOQ) of Desloratadine, Directly Taken From Analytical Data (tlast)
Time of last concentration above LLOQ, directly taken from analytical data.
Time frame: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of Loratadine
Half-life associated with the terminal slope.
Time frame: 0 h (pre-dose) to 72 h post-dose
Percentage of Area Under the Concentration Versus Time Curve (AUC) from the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) to Infinity (%AUC[tlast-∞]) of Desoratadine After Single Oral Administration of Loratadine
Percentage of area under the concentration versus time curve from zero to the last data point \> LLOQ in plasma (AUC\[(0-tlast\]) was measured.
Time frame: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine
Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points \> LLOQ.
Time frame: 0 h (pre-dose) to 72 h post-dose