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

• ClinicalTrials.gov Identifier: NCT03517943
• Recruitment Status: Completed
• First Posted: May 8, 2018
• Last Update Posted: September 13, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 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 Fed Conditions in Healthy Adult Subjects
• Actual Study Start Date: April 24, 2018
• Actual Primary Completion Date: August 30, 2018
• Actual Study Completion Date: August 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test treatment; Healthy adult subjects under fed 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 fed 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)

Outcome Measures

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. 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.
2. %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
3. 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
4. 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.
5. 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
6. 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
7. 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
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. Number of participants with adverse events [ Time Frame: Up to 26 days ]

Eligibility Criteria

• 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
• Be willing and able to consume all contents of the standardized breakfast within 30 minutes of dosing

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)

Contacts and Locations

Locations

United States, New Jersey

Frontage Clinical Services

Secaucus, New Jersey, United States, 07094

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03517943
• Other Study ID Numbers: 19626
• First Posted: May 8, 2018
• Last Update Posted: September 13, 2018
• Last Verified: September 2018

• 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:

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