PainPhase 1NCT02549469
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
A Phase 1 study testing Naproxen Sodium ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC and Naproxen Sodium ER (BAY117031), 40% HPMC in people with Pain, run by Bayer.
Trial summary
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet. 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 ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC and Naproxen Sodium ER (BAY117031), 40% HPMC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2007
- 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 18 to 55 years of age, inclusive
- Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
- Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or 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., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
- Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.
Who cannot join
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
- Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
- Females who are pregnant or lactating
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).
About this study
Official title: A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
- Conditions
- Pain
- Being tested
- Naproxen Sodium ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC, Naproxen Sodium ER (BAY117031), 40% HPMC, Aleve (Naproxen Sodium, BAY117031)
- 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 ER (BAY117031), 20% HPMCDrug
1 tablet 660 mg administered orally once daily
Naproxen Sodium ER (BAY117031), 30% HPMCDrug
1 tablet 660 mg administered orally once daily
Naproxen Sodium ER (BAY117031), 40% HPMCDrug
1 tablet 660 mg administered orally once daily
Aleve (Naproxen Sodium, BAY117031)Drug
1 tablet 220 mg administered orally three times daily
| Study group | Role | What they receive |
|---|---|---|
| Naproxen sodium extended release 660 mg, 20% HPMC | Experimental | Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet Receives: Drug: Naproxen Sodium ER (BAY117031), 20% HPMC |
| Naproxen sodium extended release 660 mg, 30% HPMC | Experimental | Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet Receives: Drug: Naproxen Sodium ER (BAY117031), 30% HPMC |
| Naproxen sodium extended release 660 mg, 40% HPMC | Experimental | Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet Receives: Drug: Naproxen Sodium ER (BAY117031), 40% HPMC |
| Naproxen sodium 220 mg | Active comparator | Bioequivalence in healthy adult subjects in a fasted state Receives: Drug: Aleve (Naproxen Sodium, BAY117031) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum plasma concentration) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC0-24 (partial area under the curve ) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium
Measured: Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium
Measured: Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium
Measured: Days 0, 1, 2, and 3
λz (terminal elimination rate constant)
Measured: Days 0, 1, 2, and 3
t1/2 (terminal half life)
Measured: Days 0, 1, 2, and 3
Secondary outcomes (7)
Adverse events (AEs) collection
Measured: up to 50 days
Serious adverse events (SAEs) collection
Measured: up to 50 days
Vital signs: sitting blood pressure
Measured: up to 50 days
Vital signs: repiratory rate
Measured: up to 50 days
Vital signs : pulse rate
Measured: up to 50 days
Clinical Laboratory data
Blood and urine samples were collected according to standard medical guidelines at the Screening Visit. In addition, hematology and chemistry were obtained at the end of the study (EOS).
Measured: up to 50 days
Physical examination findings
Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS
Measured: up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2007
- Primary completionMay 2007
- Study completionMay 2007
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
- 32 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
- NCT02549469
- Sponsor's protocol ID
- 12656
- Status last verified
- Sep 2015
- First submitted
- 17 Aug 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
- ClinicalTrials.gov ID
- NCT02549469
- Acronym / sponsor ID
- 12656
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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.
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Naproxen sodium extended release 660 mg, 20% HPMC | Experimental | Drug: Naproxen Sodium ER (BAY117031), 20% HPMCBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet |
| Naproxen sodium extended release 660 mg, 30% HPMC | Experimental | Drug: Naproxen Sodium ER (BAY117031), 30% HPMCBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet |
| Naproxen sodium extended release 660 mg, 40% HPMC | Experimental | Drug: Naproxen Sodium ER (BAY117031), 40% HPMCBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet |
| Naproxen sodium 220 mg | Active comparator | Drug: Aleve (Naproxen Sodium, BAY117031)Bioequivalence in healthy adult subjects in a fasted state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
- Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
- Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or 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., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
- Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.
Key exclusion criteria (8 listed)
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
- Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
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 ER (BAY117031), 20% HPMC1 tablet 660 mg administered orally once daily | Drug | Naproxen sodium extended release 660 mg, 20% HPMC |
| Naproxen Sodium ER (BAY117031), 30% HPMC1 tablet 660 mg administered orally once daily | Drug | Naproxen sodium extended release 660 mg, 30% HPMC |
| Naproxen Sodium ER (BAY117031), 40% HPMC1 tablet 660 mg administered orally once daily | Drug | Naproxen sodium extended release 660 mg, 40% HPMC |
| Aleve (Naproxen Sodium, BAY117031)1 tablet 220 mg administered orally three times daily | Drug | Naproxen sodium 220 mg |
Primary outcome
Cmax (maximum plasma concentration) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-24 (partial area under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
λz (terminal elimination rate constant)
Time frame: Days 0, 1, 2, and 3
t1/2 (terminal half life)
Time frame: Days 0, 1, 2, and 3
7 secondary outcomes
Adverse events (AEs) collection
Time frame: up to 50 days
Serious adverse events (SAEs) collection
Time frame: up to 50 days
Vital signs: sitting blood pressure
Time frame: up to 50 days
Vital signs: repiratory rate
Time frame: up to 50 days
Vital signs : pulse rate
Time frame: up to 50 days
Clinical Laboratory data
Time frame: up to 50 days
Physical examination findings
Time frame: up to 50 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 15 Sep 2015.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naproxen Sodium ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC and Naproxen Sodium ER (BAY117031), 40% HPMC in people with Pain, run by Bayer.
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 5 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax (maximum plasma concentration) for naproxen sodium (time frame: Days 0, 1, 2, and 3). The study lists 10 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 15 Sep 2015.