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

NCT ID: NCT03517930

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2018-07-20

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.

Conditions

Clinical Pharmacology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test treatment

Healthy adult subjects under fasted conditions

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Reference treatment

Healthy adult subjects under fasted conditions

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Frontage Clinical Services

Secaucus, New Jersey, United States

Countries

United States

Other Identifiers

19625

Identifier Type: -

Identifier Source: org_study_id