HealthyPhase 1NCT01052792
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
A Phase 1 study testing Naproxen Sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naproxen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- May 2006to Jun 2006
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy human subjects within the age range of 18 to 45 years.
- Non-smokers since at least six months.
- Willingness to provide written informed consent to participate in the study.
- Body-mass index of ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2, witQ body weight not less than 50 kg.
- Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
- Normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
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- Normal chest X-ray PA view.
- Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
- Female Subjects:
- of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) such as condoms, foams jellies, diaphragm, intrauterine device {IUD}, or abstinence or postmenopausal for at least 1 year, or surgically sterile {bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.
Who cannot join
- Personal/family history of allergy or hypersensitivity to Naproxen sodium or allied drugs.
- Past history of anaphylaxis or angioedema.
- Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- Presence of any clinically significant abnormal values during screening e.g significant abnormality of liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
- Any cardiac, renal or liver impairment any other organ or system impairment.
- History of seizure or psychiatric disorders.
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- Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus.
- Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study {one drink is equal to one unit of alcohol {one glass wine half pint beer, and one measure (one ounce) of spirit].
- Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period.
- Use of any recreational drug or a history of drug addiction.
- Participation in any clinical trial within the past 3 months.
- Inaccessibility of veins in left and right arm.
- Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication.
- Receipt of any prescription drug therapy within four weeks or over-the-counter {OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks.
- An unusual diet, for whatever reason e.g. low sodium diet for two weeks prior to receiving any medication and through out subject's participation in the study.
- Consumption of grapefruit-containing food or beverages within 7 days prior to receiving the first dose of study medication in both the periods.
- Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
- Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Randomised,Two-treatment,Two-period,Two-sequence,Single-dose, Crossover,Comparative Bioequivalence Study of Naproxen Sodium 550 mg Tablets With ANAPROX® DS 550 mg Tablets in Healthy,Adult, Human Subjects Under Fed Conditions
An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
Read the detailed description
The study was an open label, randomised, two-treatment,two-period, two-sequence, single-dose, crossover,comparative bioequivalence study of Naproxen Sodium 550 mg tablets (containing naproxen 500 mg) manufactured by Dr. Reddy's Laboratories, ltd, Generics, India compared with ANAPROX® DS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche Laboratories Inc. 340 Kingsland Street, New Jersey; in healthy,adult, human subjects under fed conditions with a wash out period of 10 days between two periods.
- Conditions
- Healthy
- Being tested
- Naproxen Sodium
- Keywords
- Bioequivalence, Naproxen, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen SodiumDrug
Also called Anaprox DS 550 mg
Naproxen Sodium Tablets 550 mg
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium 550 mg Tablets | Experimental | Naproxen Sodium 550 mg Tablets of Dr. Reddy's Laboratories Limited Receives: Drug: Naproxen Sodium |
| Anaprox DS 550mg Tablets | Active comparator | Anaprox DS 550mg Tablets of Roche Pharmaceuticals Inc Receives: Drug: Naproxen Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Umesh Dhakate, MBBS, Principal investigator, Wellquest Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052792
- Sponsor's protocol ID
- CR-BE-138-NAPR-2005
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomised,Two-treatment,Two-period,Two-sequence,Single-dose, Crossover,Comparative Bioequivalence Study of Naproxen Sodium 550 mg Tablets With ANAPROX® DS 550 mg Tablets in Healthy,Adult, Human Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01052792
- Acronym / sponsor ID
- CR-BE-138-NAPR-2005
- Conditions
- Healthy
- Keywords
- Bioequivalence, Naproxen, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Jan 2010 (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.
An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
Detailed description
The study was an open label, randomised, two-treatment,two-period, two-sequence, single-dose, crossover,comparative bioequivalence study of Naproxen Sodium 550 mg tablets (containing naproxen 500 mg) manufactured by Dr. Reddy's Laboratories, ltd, Generics, India compared with ANAPROX® DS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche Laboratories Inc. 340 Kingsland Street, New Jersey; in healthy,adult, human subjects under fed conditions with a wash out period of 10 days between two periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium 550 mg Tablets | Experimental | Drug: Naproxen SodiumNaproxen Sodium 550 mg Tablets of Dr. Reddy's Laboratories Limited |
| Anaprox DS 550mg Tablets | Active comparator | Drug: Naproxen SodiumAnaprox DS 550mg Tablets of Roche Pharmaceuticals Inc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy human subjects within the age range of 18 to 45 years.
- Non-smokers since at least six months.
- Willingness to provide written informed consent to participate in the study.
- Body-mass index of ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2, witQ body weight not less than 50 kg.
- Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
Key exclusion criteria (18 listed)
- Personal/family history of allergy or hypersensitivity to Naproxen sodium or allied drugs.
- Past history of anaphylaxis or angioedema.
- Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- Presence of any clinically significant abnormal values during screening e.g significant abnormality of liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
- Any cardiac, renal or liver impairment any other organ or system impairment.
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 SodiumAlso: Anaprox DS 550 mgNaproxen Sodium Tablets 550 mg | Drug | Anaprox DS 550mg Tablets, Naproxen Sodium 550 mg Tablets |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
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 Jan 2010.
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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.
Dr. Umesh Dhakate, MBBS principal investigator
Wellquest Clinical Research
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 Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 10 inclusion and 18 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 Jan 2010. 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 India. 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?
Bioequivalence based on Cmax and AUC parameters (time frame: 3 months). 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 Jan 2010.