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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03517930
Other study ID # 19625
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 17, 2018
Est. completion date July 20, 2018

Study information

Verified date September 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date July 20, 2018
Est. primary completion date July 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Frontage Clinical Services Secaucus New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC(0-tlast) of loratadine and pseudoephedrine Area under the curve from time 0 to the last measurable concentration. 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
Primary Cmax of loratadine and pseudoephedrine Maximum observed plasma level 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 CL/F for loratadine, pseudoephedrine and desloratadine Total body oral clearance 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 Number of participants with adverse event Up to 26 days
Secondary %AUC(tlast-8) for loratadine, pseudoephedrine and desloratadine Percentage of AUC from last data point > lower limit of quantification (LLOQ) to infinity 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 Tmax for loratadine, pseudoephedrine and desloratadine Time at which Cmax is observed 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 Tlast for loratadine, pseudoephedrine and desloratadine Time point for last measurable concentration. 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 ?z for loratadine, pseudoephedrine and desloratadine Terminal elimination rate constant 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 t1/2 for loratadine, pseudoephedrine and desloratadine Half-life 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 AUC(0-tlast) for desloratadine Area under the curve from time 0 to the last measurable concentration. 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 Cmax for desloratadine Maximum observed plasma level 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 AUC for loratadine, pseudoephedrine and desloratadine Area under the curve from time 0 to infinity. 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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