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CompletedNCT03517930Updated Sep 19, 2018

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

A Phase 1 interventional study of Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) and Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist) in Clinical Pharmacology, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Bayer · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Clinical Pharmacology

Keywords

  • Upper respiratory allergy symptoms including congestion
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Test treatment

    Healthy adult subjects under fasted conditions

    Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) · Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)

  • Active comparator
    Reference treatment

    Healthy adult subjects under fasted conditions

    Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) · Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)

Interventions

  • DrugLoratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)

    Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

  • DrugLoratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)

    Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

06

What researchers measure

Primary outcomes

  1. AUC(0-tlast) of loratadine and pseudoephedrine

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

    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

  2. Cmax of loratadine and pseudoephedrine

    Maximum observed plasma level

    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

Secondary outcomes

  1. CL/F for loratadine, pseudoephedrine and desloratadine

    Total body oral clearance

    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

  2. Number of participants with adverse event

    Time frame: Up to 26 days

  3. %AUC(tlast-∞) for loratadine, pseudoephedrine and desloratadine

    Percentage of AUC from last data point \> lower limit of quantification (LLOQ) to infinity

    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

  4. Tmax for loratadine, pseudoephedrine and desloratadine

    Time at which Cmax is observed

    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

  5. Tlast for loratadine, pseudoephedrine and desloratadine

    Time point for last measurable concentration.

    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

  6. λz for loratadine, pseudoephedrine and desloratadine

    Terminal elimination rate constant

    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

  7. t1/2 for loratadine, pseudoephedrine and desloratadine

    Half-life

    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

  8. AUC(0-tlast) for desloratadine

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

    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

  9. Cmax for desloratadine

    Maximum observed plasma level

    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

  10. AUC for loratadine, pseudoephedrine and desloratadine

    Area under the curve from time 0 to infinity.

    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

07

Study locations

1 site
  • Frontage Clinical Services
    Secaucus, New Jersey 07094, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03517930
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
May 8, 2018
Start date
Apr 17, 2018
Primary completion
Jul 20, 2018
Completion
Jul 20, 2018
Last update
Sep 19, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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