Clinical PharmacologyPhase 1NCT03424135

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions

A Phase 1 study testing Naproxen sodium and diphenhydramine hydrochloride soft capsules and Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111) 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

To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg combination product) under fed conditions in… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Clinical Pharmacology
What is being tested?: Naproxen sodium and diphenhydramine hydrochloride soft capsules and Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2018to 4 Apr 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, ambulatory male and female subjects between 18 to 55 years of age inclusive;
Body Mass Index (BMI) in the range of 18 to 30 kg/m2 inclusive; and a total body weight >50 kg (110 lbs.);
Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator and Sponsor;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier] and have a negative pregnancy test at Screening and prior to study drug administration on Day -1 of Dosing Periods 1 and 2. Female subjects of non-childbearing potential must be amenorrheic for at least two years or have had a hysterectomy and/or bilateral oophorectomy;

Who cannot join

History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid (ASA), other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;
Females who are pregnant or lactating;
Vegetarian or restricted diet (e.g., gluten-free);
Any active disease, acute or chronic;
Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid, ASA-containing products, acetaminophen, ibuprofen, any other NSAIDs (Over-the-Counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g., coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;
Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;

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Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;
Positive test for hepatitis B surface antigen (HBsAg) test;
Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;
In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;
Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;
More than moderate alcohol consumption (>40 g of alcohol regularly per day);
Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.
Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;
Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml or greater within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
Excessive sports or sauna within 5 days before start of the treatment phase and willing to abstain during the trial;
Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;
History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary (including emphysema and chronic bronchitis), gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, (including glaucoma or benign prostatic hypertrophy) or malignancies or any disease or condition which could influence the metabolism of the drug;
Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product within the previous three months (e.g., nicotine patch, nicotine gum);
Not willing to abstain from any xanthine-containing or grapefruit/ pomelos -containing food/beverages during the study;
Have a previous medical history of gout or reduced uric acid excretion;
Alcoholism or drug abuse within 2 years prior to the Screening Visit;
Consumed alcohol within 24 hours prior to dosing of investigational medicinal product (IMP) in the study center on study days (verified by saliva/breath alcohol test on Day -1 of each Dosing Period);
Current or past history of controlled substance dependence;
Current participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit;
Member or relative of study staff or the Sponsor directly involved in the study;
Unwilling or unable to comply with all requirements outlined in the protocol
Subjects with a medical disorder, condition, or history of such that could impair the subject's ability to participate or complete this trial in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON Development Solutions, LLC
San Antonio, Texas, 78219

Other trials in United States

About this study

Official title: An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions

To assess the safety and tolerability of the investigational products in terms of adverse events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical examination, clinical and laboratory testing).

Conditions: Clinical Pharmacology
Being tested: Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)

What participants receive

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

Naproxen sodium and diphenhydramine hydrochloride soft capsulesDrug
Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)
Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)Drug
Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)

Study groups in NCT03424135
Study group	Role	What they receive
Test product + Reference product	Experimental	Each treatment sequence consists of two treatment periods (Dosing Periods 1 and 2) with each period consisting of 4 days starting with an overnight fast of at least 10 hours. Subjects will consume a standardized high calorie, high fat breakfast approximately 30 minutes prior to dosing followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two study drug administrations are separated by a 7 calendar days washout phase. Receives: Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsules; Drug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
Reference product + Test product	Experimental	Each treatment sequence consists of two treatment periods (Dosing Periods 1 and 2) with each period consisting of 4 days starting with an overnight fast of at least 10 hours. Subjects will consume a standardized high calorie, high fat breakfast approximately 30 minutes prior to dosing followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two study drug administrations are separated by a 7 calendar days washout phase. Receives: Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsules; Drug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)

What is being measured

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

AUC
Area under the concentration vs. time curve from zero to infinity after single (first) dose
Measured: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
AUC(0-tlast)
Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule
Measured: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Cmax
Maximum observed drug concentration, directly observed from analytical data
Measured: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Secondary outcomes (1)

Number of adverse events as a measure of safety and tolerability
Measured: Up to 5 weeks

Timeline

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

2 Mar 20184 Apr 2018

First posted6 Feb 2018
Study start2 Mar 2018
Primary completion4 Apr 2018
Study completion4 Apr 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03424135
Sponsor's protocol ID: 17944
Status last verified: Mar 2019
First submitted: 1 Feb 2018
Last updated: 20 Mar 2019
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
ClinicalTrials.gov ID: NCT03424135
Acronym / sponsor ID: 17944
Conditions: Clinical Pharmacology
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 2 Mar 2018 (actual)
Primary completion: 4 Apr 2018 (actual)
Study completion: 4 Apr 2018 (actual)
First posted: 6 Feb 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test product + Reference product	Experimental	Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsules, Drug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)Each treatment sequence consists of two treatment periods (Dosing Periods 1 and 2) with each period consisting of 4 days starting with an overnight fast of at least 10 hours. Subjects will consume a standardized high calorie, high fat breakfast approximately 30 minutes prior to dosing followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two study drug administrations are separated by a 7 calendar days washout phase.
Reference product + Test product	Experimental	Drug: Naproxen sodium and diphenhydramine hydrochloride soft capsules, Drug: Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)Each treatment sequence consists of two treatment periods (Dosing Periods 1 and 2) with each period consisting of 4 days starting with an overnight fast of at least 10 hours. Subjects will consume a standardized high calorie, high fat breakfast approximately 30 minutes prior to dosing followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two study drug administrations are separated by a 7 calendar days washout phase.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy, ambulatory male and female subjects between 18 to 55 years of age inclusive;
Body Mass Index (BMI) in the range of 18 to 30 kg/m2 inclusive; and a total body weight >50 kg (110 lbs.);
Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator and Sponsor;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier] and have a negative pregnancy test at Screening and prior to study drug administration on Day -1 of Dosing Periods 1 and 2. Female subjects of non-childbearing potential must be amenorrheic for at least two years or have had a hysterectomy and/or bilateral oophorectomy;

Key exclusion criteria (29 listed)

History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid (ASA), other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;
Females who are pregnant or lactating;
Vegetarian or restricted diet (e.g., gluten-free);
Any active disease, acute or chronic;
Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid, ASA-containing products, acetaminophen, ibuprofen, any other NSAIDs (Over-the-Counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g., coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;

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
Naproxen sodium and diphenhydramine hydrochloride soft capsulesSingle oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)	Drug	Reference product + Test product, Test product + Reference product
Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)	Drug	Reference product + Test product, Test product + Reference product

Primary outcome

AUC
Time frame: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Area under the concentration vs. time curve from zero to infinity after single (first) dose
AUC(0-tlast)
Time frame: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule
Cmax
Time frame: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Maximum observed drug concentration, directly observed from analytical data

1 secondary outcome

Number of adverse events as a measure of safety and tolerability
Time frame: Up to 5 weeks

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 20 Mar 2019.

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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.

Bayer Study Director study director

Bayer

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 29 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 20 Mar 2019. 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 (time frame: Within 30 minutes prior to dosing (baseline) 20, 40, 60 minutes and 1 h 30 min, 2 h, 2 h 20 min, 2 h 40 min, 3, 3 h 20 min, 3 h 40 min, 4 h, 4 h 30 min, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.). The study lists 3 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 NCT03424135.

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 20 Mar 2019.