BioequivalencyPhase 1NCT00804401
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions
A Phase 1 study testing Naproxen Tablets, 500 mg in people with Bioequivalency, run by Perrigo Company.
Trial summary
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalency
- What is being tested?
- Naproxen Tablets, 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jul 2004
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men or women, non-smoker, 18 years of age or older
- willing to participate and sign a copy of the informed consent form
Who cannot join
- clinically significant illnesses or surgery within 4 weeks prior to study dosing
- body mass index greater than or equal to 30.0
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
- history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
Show all 10Show fewer
- history or known presence of gastrointestinal ulceration, bleeding and perforation
- use of tobacco products within 6 months prior to study dosing
- evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- receipt of any drugs as part of a research study within 30 days prior to study dosing
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.
- Conditions
- Bioequivalency
- Being tested
- Naproxen Tablets, 500 mg
- Keywords
- bioequivalency, Naproxen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Tablets, 500 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Active comparator | Not described Receives: Drug: Naproxen Tablets, 500 mg |
| Reference Product | Active comparator | Not described Receives: Drug: Naproxen Tablets, 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJun 2004
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalencyStudies of the same condition, open and under way.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrigo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804401
- Sponsor's protocol ID
- 40061
- Status last verified
- Mar 2012
- First submitted
- 5 Dec 2008
- Last updated
- 16 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00804401
- Acronym / sponsor ID
- 40061
- Conditions
- Bioequivalency
- Keywords
- bioequivalency, Naproxen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Perrigo CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2004 (actual)
- First posted
- 8 Dec 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.
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Active comparator | Drug: Naproxen Tablets, 500 mg |
| Reference Product | Active comparator | Drug: Naproxen Tablets, 500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy men or women, non-smoker, 18 years of age or older
- willing to participate and sign a copy of the informed consent form
Key exclusion criteria (10 listed)
- clinically significant illnesses or surgery within 4 weeks prior to study dosing
- body mass index greater than or equal to 30.0
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
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 Tablets, 500 mg | Drug | Reference Product, Test Product |
Primary outcome
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
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 16 Mar 2012.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naproxen Tablets, 500 mg in people with Bioequivalency, run by Perrigo Company.
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 2 inclusion and 10 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 16 Mar 2012. 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?
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity. 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 16 Mar 2012.