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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

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ClinicalTrials.gov Identifier: NCT03517930
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clinical Pharmacology Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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 Fasted Conditions in Healthy Adult Subjects
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018


Arm Intervention/treatment
Experimental: Test treatment
Healthy adult subjects under fasted conditions
Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)
Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

Active Comparator: Reference treatment
Healthy adult subjects under fasted conditions
Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)
Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)




Primary Outcome Measures :
  1. AUC(0-tlast) of loratadine and pseudoephedrine [ Time 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 ]
    Area under the curve from time 0 to the last measurable concentration.

  2. Cmax of loratadine and pseudoephedrine [ Time 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 ]
    Maximum observed plasma level


Secondary Outcome Measures :
  1. CL/F for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Total body oral clearance

  2. Number of participants with adverse event [ Time Frame: Up to 26 days ]
  3. %AUC(tlast-∞) for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Percentage of AUC from last data point > lower limit of quantification (LLOQ) to infinity

  4. Tmax for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Time at which Cmax is observed

  5. Tlast for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Time point for last measurable concentration.

  6. λz for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Terminal elimination rate constant

  7. t1/2 for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Half-life

  8. AUC(0-tlast) for desloratadine [ Time 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 ]
    Area under the curve from time 0 to the last measurable concentration.

  9. Cmax for desloratadine [ Time 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 ]
    Maximum observed plasma level

  10. AUC for loratadine, pseudoephedrine and desloratadine [ Time 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 ]
    Area under the curve from time 0 to infinity.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517930


Locations
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United States, New Jersey
Frontage Clinical Services
Secaucus, New Jersey, United States, 07094
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03517930     History of Changes
Other Study ID Numbers: 19625
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bayer:
Upper respiratory allergy symptoms including congestion

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Pseudoephedrine
Loratadine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents