PainPhase 1NCT03396250
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects
A Phase 1 study testing Naproxen sodium and diphenhydramine hydrochloride soft capsules and Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111) in people with Pain, run by Bayer at 1 site in United States.
Trial summary
To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Naproxen sodium and diphenhydramine hydrochloride soft capsules and Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 29 Mar 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/m2 inclusive
Who cannot join
- History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, 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), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (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 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 unwilling 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, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Development Solutions, LLC
San Antonio, Texas, 78219
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 Fasted Conditions
To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.
To assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.
- Conditions
- Pain
- Being tested
- Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)
- Medical subject headings
- Pain
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, PMBAY98-7111)Drug
Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Test product + Reference product | Experimental | Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two 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, PMBAY98-7111) |
| Reference product + Test product | Experimental | Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two 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, PMBAY98-7111) |
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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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.
- First posted10 Jan 2018
- Study start12 Feb 2018
- Primary completion26 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396250
- Sponsor's protocol ID
- 17934
- Status last verified
- Mar 2019
- First submitted
- 5 Jan 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Fasted Conditions
- ClinicalTrials.gov ID
- NCT03396250
- Acronym / sponsor ID
- 17934
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 10 Jan 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.
To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.
To assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.
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, PMBAY98-7111)Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two 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, PMBAY98-7111)Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two 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 (3 listed)
- Healthy adult men or women
- Age 18 to 55 years inclusive;
- Body mass index 18.5 to 30.0 kg/m2 inclusive
Key exclusion criteria (19 listed)
- History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, 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), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (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, PMBAY98-7111)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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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?
A Phase 1 study testing Naproxen sodium and diphenhydramine hydrochloride soft capsules and Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111) in people with Pain, run by Bayer at 1 site in United States.
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 3 inclusion and 19 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) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 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?
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.