Clinical PharmacologyPhase 1NCT03517943

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

A Phase 1 study testing Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) and Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist) in people with Clinical Pharmacology, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Clinical Pharmacology
What is being tested?: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) and Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2018to 30 Aug 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Frontage Clinical Services
Secaucus, New Jersey, 07094

Other trials in United States

About this study

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

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
Being tested: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG), Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Keywords: Upper respiratory allergy symptoms including congestion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03517943
Study group	Role	What they receive
Test treatment	Experimental	Healthy adult subjects under fed conditions Receives: Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG); Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Reference treatment	Active comparator	Healthy adult subjects under fed conditions Receives: Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG); Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-tlast) of loratadine and pseudoephedrine
Area under the curve from time 0 to the last measurable concentration.
Measured: 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
Cmax of loratadine and pseudoephedrine
Maximum observed plasma level
Measured: 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 outcomes (10)

AUC for loratadine, pseudoephedrine and desloratadine
Area under the curve from time 0 to infinity.
Measured: 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
%AUC(tlast-∞) for loratadine, pseudoephedrine and desloratadine
Percentage of AUC from last data point > Lower limit of quantification (LLOQ) to infinity
Measured: 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
Tmax for loratadine, pseudoephedrine and desloratadine
Time at which Cmax is observed
Measured: 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
Tlast for loratadine, pseudoephedrine and desloratadine
Time point for last measurable concentration.
Measured: 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
λz for loratadine, pseudoephedrine and desloratadine
Terminal elimination rate constant
Measured: 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
t1/2 for loratadine, pseudoephedrine and desloratadine
Half-life
Measured: 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
CL/F for loratadine, pseudoephedrine and desloratadine
Total body oral clearance
Measured: 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
AUC(0-tlast) for desloratadine
Area under the curve from time 0 to the last measurable concentration.
Measured: 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
Cmax for desloratadine
Maximum observed plasma level
Measured: 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
Number of participants with adverse events
Measured: Up to 26 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201830 Aug 2018

First posted8 May 2018
Study start24 Apr 2018
Primary completion30 Aug 2018
Study completion30 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03517943
Sponsor's protocol ID: 19626
Status last verified: Sep 2018
First submitted: 17 Apr 2018
Last updated: 13 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03517943
Acronym / sponsor ID: 19626
Conditions: Clinical Pharmacology
Keywords: Upper respiratory allergy symptoms including congestion
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 24 Apr 2018 (actual)
Primary completion: 30 Aug 2018 (actual)
Study completion: 30 Aug 2018 (actual)
First posted: 8 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test treatment	Experimental	Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG), Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)Healthy adult subjects under fed conditions
Reference treatment	Active comparator	Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG), Drug: Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)Healthy adult subjects under fed conditions

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)	Drug	Reference treatment, Test treatment
Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)	Drug	Reference treatment, Test treatment

Primary outcome

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.
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

10 secondary outcomes

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
%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
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
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
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
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
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
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
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
Number of participants with adverse events
Time frame: Up to 26 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03517943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.