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Loratadine

Phase 1

Clinical Pharmacology | Small molecule | Other |Bayer AG|Last Updated: Sep 19, 2018

Target and mechanism

ModalitySmall molecule

Also known as Loratadine oral solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

Loratadine · 3 trials · 2 indications

Phase 1 3
NCT03517943A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult SubjectsClinical Pharmacology
COMPLETED29 Analytics
NCT03517930A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult SubjectsClinical Pharmacology
COMPLETED52 Analytics
NCT02593747To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach SyrupHistamine H1 Antagonists, Non-Sedating
COMPLETED54 Analytics
PHASE1COMPLETED
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects
Clinical Pharmacology
NCT0351794329
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PHASE1COMPLETED
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
Clinical Pharmacology
NCT0351793052
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PHASE1COMPLETED
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
Histamine H1 Antagonists, Non-Sedating
NCT0259374754
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Study Endpoints

Primary Endpoints

AUC(0-tlast) of loratadine and pseudoephedrine
Baseline (within 60 minutes of dosing) and at 15, 30, 45, 60 minutes and 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose in each treatment period

Area under the curve from time 0 to the last measurable concentration.

Cmax of loratadine and pseudoephedrine
Baseline (within 60 minutes of dosing) and at 15, 30, 45, 60 minutes and 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose in each treatment period

Maximum observed plasma level

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
0 hour (h) (pre-dose) to 72 h post-dose

Area under the concentration versus time curve from zero to the last data point greater than (\>) LLOQ (AUC\[0-tlast\]) after single dose.

Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
0 h (pre-dose) to 72 h post-dose

Maximum observed loratadine concentration in plasma, directly taken from analytical data.

Secondary Endpoints

AUC for loratadine, pseudoephedrine and desloratadine
Baseline (within 60 minutes of dosing) and at 15, 30, 45, 60 minutes and 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose in each treatment period
%AUC(tlast-∞) for loratadine, pseudoephedrine and desloratadine
Baseline (within 60 minutes of dosing) and at 15, 30, 45, 60 minutes and 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose in each treatment period
Tmax for loratadine, pseudoephedrine and desloratadine
Baseline (within 60 minutes of dosing) and at 15, 30, 45, 60 minutes and 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose in each treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Test treatmentEXPERIMENTALHealthy adult subjects under fed conditions
Reference treatmentACTIVE_COMPARATORHealthy adult subjects under fed conditions
Loratadine oral solution/syrup then Claritin peach syrupEXPERIMENTALSubjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.
Claritin peach syrup then Loratadine oral solution/syrupEXPERIMENTALSubjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments.

Interventions

NameTypeDescription
Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)DRUGOral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)DRUGOral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
Loratadine oral solutionDRUGSubjects 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.
Loratadine (Claritin peach syrup)DRUGSubjects 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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult men or women * Age 18 to 55 years inclusive * Body mass index 18.5 to 30.0 kg/m\*2 inclusive * Be willing and able to consume all contents of the standardized breakfast within 30 minutes of dosing Exclusion Criteria: * Positive alcohol or drug screen at Screeni...

Countries:United StatesGermany
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