BioavailabilityPhase 1KeiferNCT00692016
Fast & Fed Pharmacokinetic (PK) Study
A Phase 1 study testing Naproxen sodium in people with Bioavailability, run by Bayer at 1 site in United States.
Trial summary
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Naproxen sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2008
- 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 volunteers between 18 to 55 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2, 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 the 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, NuvaRing®, Depo-Provera®, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each dosing period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
Who cannot join
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products;
- Females who are pregnant or lactating;
- Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
- 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 or malignancies;
- Positive alcohol or drug test;
Show all 12Show fewer
- Have taken any medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the study, unless in the opinion of the Investigator and the Sponsor, the medication will not interfere with the study procedures, data integrity, or compromise the safety of the subject;
- 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;
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum);
- Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the study;
- Alcoholism or drug abuse within 2 years prior to the Screening Visit;
- Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-Way Crossover Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).
- Conditions
- Bioavailability
- Being tested
- Naproxen sodium
- Keywords
- Naproxen Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen sodiumDrug
Administered under fasting condition
Naproxen sodiumDrug
Administered under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Naproxen sodium |
| Arm 2 | Other | Not described Receives: Drug: Naproxen sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters
Measured: Over 48 hours
Secondary outcomes (1)
Assess the tolerability of the investigational product.
Measured: Over 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692016
- Sponsor's protocol ID
- 13080
- Acronym
- Keifer
- Status last verified
- May 2013
- First submitted
- 5 Jun 2008
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-Way Crossover Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT00692016
- Acronym / sponsor ID
- Keifer / 13080
- Conditions
- Bioavailability
- Keywords
- Naproxen Sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Jun 2008 (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.
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Naproxen sodium |
| Arm 2 | Other | Drug: Naproxen sodium |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, ambulatory, male and female volunteers between 18 to 55 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2, 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 the 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, NuvaRing®, Depo-Provera®, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each dosing period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
Key exclusion criteria (12 listed)
- History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products;
- Females who are pregnant or lactating;
- Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
- 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 or malignancies;
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 sodiumAdministered under fasting condition | Drug | Arm 1 |
| Naproxen sodiumAdministered under fed condition | Drug | Arm 2 |
Primary outcome
PK parameters
Time frame: Over 48 hours
1 secondary outcome
Assess the tolerability of the investigational product.
Time frame: Over 48 hours
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 3 May 2013.
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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 in people with Bioavailability, 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 12 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 3 May 2013. 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?
PK parameters (time frame: Over 48 hours). 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 3 May 2013.