check_circleStudy Completed
Histamine H1 Antagonists, Non-Sedating
Bayer Identifier:
18199
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
To assess bioequivalence of Loratadine Oral Solution/Syrup versus Claritin Peach Syrup
Trial purpose
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
54Trial Dates
December 2015 - March 2016Phase
Phase 1Could I Receive a placebo
NoProducts
CLARITIN (Loratadine, BAY76-2211)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Neu-Ulm, 89231, Germany |
Primary Outcome
- 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 LoratadineArea under the concentration versus time curve from zero to the last data point greater than (>) LLOQ (AUC[0-tlast]) after single dose.date_rangeTime Frame:0 hour (h) (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of LoratadineMaximum observed loratadine concentration in plasma, directly taken from analytical data.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of LoratadineTime to reach maximum loratadine concentration in plasma after its single oral dose, directly taken from analytical data.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single DoseArea under the concentration versus time curve from zero to infinity after single dose.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single DoseHalf-life associated with the terminal slope.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral AdministrationTotal body clearance of loratadine calculated after extravascular application.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- 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 LoratadinePercentage of AUC from the last calculated data point > LLOQ to infinity was measured.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Apparent Terminal Rate Constant (λz) of Loratadine After Single DoseApparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral DoseArea under the concentration versus time curve from zero to 72 h after single dose.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of LoratadineMaximum observed desloratadine concentration in plasma, directly taken from analytical data.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of LoratadineTime to reach maximum drug concentration in the measured matrix, directly observed from the analytical data.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- 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 LoratadineArea under the concentration versus time curve from zero to the last data point > LLOQ (AUC[0-tlast]) after single dose.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Desloratadine in Plasma After Single Oral Dose of LoratadineArea 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.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of LoratadineHalf-life associated with the terminal slope.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- 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 LoratadinePercentage of area under the concentration versus time curve from zero to the last data point > LLOQ in plasma (AUC[(0-tlast]) was measured.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
- Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of LoratadineApparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ.date_rangeTime Frame:0 h (pre-dose) to 72 h post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2Additional Information
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