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

Clinical Pharmacology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517930
• Other study ID #: 19625
• Status: Completed
• Phase: Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Clinical Pharmacology

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