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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

Primary Purpose

Clinical Pharmacology

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional other trial for Clinical Pharmacology focused on measuring Upper respiratory allergy symptoms including congestion

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Frontage Clinical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test treatment

Reference treatment

Arm Description

Healthy adult subjects under fed conditions

Outcomes

Primary Outcome Measures

AUC(0-tlast) of loratadine and pseudoephedrine

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

Cmax of loratadine and pseudoephedrine

Maximum observed plasma level

Secondary Outcome Measures

AUC for loratadine, pseudoephedrine and desloratadine

Area under the curve from time 0 to infinity.

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

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

Tmax for loratadine, pseudoephedrine and desloratadine

Time at which Cmax is observed

Tlast for loratadine, pseudoephedrine and desloratadine

Time point for last measurable concentration.

λz for loratadine, pseudoephedrine and desloratadine

Terminal elimination rate constant

t1/2 for loratadine, pseudoephedrine and desloratadine

Half-life

CL/F for loratadine, pseudoephedrine and desloratadine

Total body oral clearance

AUC(0-tlast) for desloratadine

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

Cmax for desloratadine

Maximum observed plasma level

Number of participants with adverse events

Full Information

NCT ID

NCT03517943

First Posted

April 17, 2018

Last Updated

September 12, 2018

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03517943

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

April 24, 2018 (Actual)

Primary Completion Date

August 30, 2018 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinical Pharmacology

Keywords

Upper respiratory allergy symptoms including congestion

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test treatment

Arm Type

Experimental

Arm Description

Healthy adult subjects under fed conditions

Arm Title

Reference treatment

Arm Type

Active Comparator

Arm Description

Healthy adult subjects under fed conditions

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

AUC(0-tlast) of loratadine and pseudoephedrine

Description

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

Title

Cmax of loratadine and pseudoephedrine

Description

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 Outcome Measure Information:

Title

AUC for loratadine, pseudoephedrine and desloratadine

Description

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

Title

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

Description

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

Title

Tmax for loratadine, pseudoephedrine and desloratadine

Description

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

Title

Tlast for loratadine, pseudoephedrine and desloratadine

Description

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

Title

λz for loratadine, pseudoephedrine and desloratadine

Description

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

Title

t1/2 for loratadine, pseudoephedrine and desloratadine

Description

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

Title

CL/F for loratadine, pseudoephedrine and desloratadine

Description

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

Title

AUC(0-tlast) for desloratadine

Description

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

Title

Cmax for desloratadine

Description

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

Title

Number of participants with adverse events

Time Frame

Up to 26 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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 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)

Facility Information:

Facility Name

Frontage Clinical Services

City

Secaucus

State/Province

New Jersey

ZIP/Postal Code

07094

Country

United States

12. IPD Sharing Statement

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