check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
19626
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
Key Participants Requirements
Sex
AllAge
18 - 55 YearsTrial summary
Enrollment Goal
29Trial Dates
April 2018 - August 2018Phase
Phase 1Could I Receive a placebo
NoProducts
Claritin-D® (Loratadine + Pseudoephedrine sulfate, BAY818725)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Frontage Clinical Services | Secaucus, 07094, United States |
Primary Outcome
- AUC(0-tlast) of loratadine and pseudoephedrineArea under the curve from time 0 to the last measurable concentration.date_rangeTime Frame: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
- Cmax of loratadine and pseudoephedrineMaximum observed plasma leveldate_rangeTime Frame: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
Secondary Outcome
- AUC for loratadine, pseudoephedrine and desloratadineArea under the curve from time 0 to infinity.date_rangeTime Frame: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 desloratadinePercentage of AUC from last data point > Lower limit of quantification (LLOQ) to infinitydate_rangeTime Frame: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 desloratadineTime at which Cmax is observeddate_rangeTime Frame: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
- Tlast for loratadine, pseudoephedrine and desloratadineTime point for last measurable concentration.date_rangeTime Frame: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
- λz for loratadine, pseudoephedrine and desloratadineTerminal elimination rate constantdate_rangeTime Frame: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
- t1/2 for loratadine, pseudoephedrine and desloratadineHalf-lifedate_rangeTime Frame: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
- CL/F for loratadine, pseudoephedrine and desloratadineTotal body oral clearancedate_rangeTime Frame: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(0-tlast) for desloratadineArea under the curve from time 0 to the last measurable concentration.date_rangeTime Frame: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
- Cmax for desloratadineMaximum observed plasma leveldate_rangeTime Frame: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
- Number of participants with adverse eventsdate_rangeTime Frame:Up to 26 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2