check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

19626

ClinicalTrials.gov Identifier:

NCT03517943

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

All

Age

18 - 55 Years
  • - 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
  • - Positive alcohol or drug screen at Screening or on Day -1 of each dosing period;
    - Use of within 1 month before first study drug administration, systemic or topical medicines or substances which might affect the study objectives, any drug known to induce cytochrome P3A4/5 or P Glycoprotein (e.g., rifampin, carbamazepine, St. John’s wort); Any drug known to inhibit cytochrome P3A4/5 or P Glycoprotein (e.g., clarithromycin, chloramphenicol, ketoconazole);
    - History of hypersensitivity symptoms with the use of loratadine, desloratadine (Clarinex), or pseudoephedrine;
    - Females who are pregnant or lactating
    - Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids);
    - More than moderate alcohol consumption (>40 g of alcohol regularly per day);
    - Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;
    - Loss of blood of 50 mL to 499 mL within 30 days of the first dose of trial treatment, or in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)

Trial summary

Enrollment Goal
29
Trial Dates
April 2018 - August 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Claritin-D® (Loratadine + Pseudoephedrine sulfate, BAY818725)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Frontage Clinical ServicesSecaucus, 07094, United States

Primary Outcome

  • AUC(0-tlast) of loratadine and pseudoephedrine
    Area 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 pseudoephedrine
    Maximum observed plasma level
    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

Secondary Outcome

  • AUC for loratadine, pseudoephedrine and desloratadine
    Area 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 desloratadine
    Percentage of AUC from last data point > Lower limit of quantification (LLOQ) 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
  • Tmax for loratadine, pseudoephedrine and desloratadine
    Time at which Cmax is observed
    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
  • Tlast for loratadine, pseudoephedrine and desloratadine
    Time 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 desloratadine
    Terminal elimination rate constant
    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
  • t1/2 for loratadine, pseudoephedrine and desloratadine
    Half-life
    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
  • CL/F for loratadine, pseudoephedrine and desloratadine
    Total body oral clearance
    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(0-tlast) for desloratadine
    Area 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 desloratadine
    Maximum observed plasma level
    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
  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to 26 days

Trial design

A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (loratadine 5mg/pseudoephedrine sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (loratadine 5 mg/pseudoephedrine sulfate 120 mg, Manufacturer-Heist) Under Fed Conditions in Healthy Adult Subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2