HealthyPhase 1NCT01164826
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed Conditions
A Phase 1 study testing Nabumetone and Relafen in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is: To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fed conditions with a washout period of 16 days. To monitor adverse events and ensure the safety of subjects. 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?
- Nabumetone and Relafen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2006to Mar 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
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- Subjects who will provide written informed consent
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Subjects must be of normal health, as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
- Have normal ECG, X-ray and vital signs.
- Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.
Who cannot join
- The subjects will be excluded based on the following criteria:
- Subjects incapable of understanding the informed consent.
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
- Pulse rate below SO/min and above lOO/min.
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- History of hypersensitivity or idiosyncratic reaction to Nabumetone or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Clinically significant illness within 4 weeks before the start of the study.
- Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and until the completion of the study.
- Subjects who has taken over the counter or prescribed medications for during the last7 days from the date of study.
- Subjects should not have taken enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical study
- History of any psychiatric illness, which may impair the ability to provide written, informed consent.
- Subjects with clinically significant abnormal values of laboratory parameters.
- Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 330 rnL in the past 90 days before the date of start of study.
- Subjects with positive screen for drugs of abuse and alcohol.
- Any subject in whom Nabumetone is contraindicated for medical reasons.
- Any subject with recent history of surgery.
- A history of difficulty in donating blood.
- A positive hepatitis screen including hepatitis B surface antigen, anti HCV and Anti HAV antibodies
- A positive test result for HIV antibody and/or syphilis
- A recent history or presence of asthma (including aspirin induced asthma) or nasa polyp.
- A recent history of alcoholism < 2 years) or of moderate (180 mL/day) alcohol use,or consumption of alcohol within 48 hr prior to receiving Investigational Product.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the Investigational Product and throughout the subjects participation in the study. In any such case subject selection will be at the discretion of the Investigator / Medical expert.
- Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
India1 site
Bioserve Clinical Research Pvt. Ltd.
Hyderabad, Andhra Pradesh, 500037
About this study
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's and Relafen® 750 mg Tablets of Glaxosmithkline, in Healthy Subjects Under Fed Conditions
The purpose of this study is:
- To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fed conditions with a washout period of 16 days.
- To monitor adverse events and ensure the safety of subjects.
Read the detailed description
A randomized, open label, two treatment, two period, two sequence, single dose crossover, bioequivalence study of nabumetone 750 mg tablets of Dr. Reddy's Laboratories Limited and Relafen® 750 mg tablets of Glaxosmithkline research triangle park, in healthy, adult, human subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Nabumetone, Relafen
- Keywords
- Bioequivalence, Crossover, Nabumetone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabumetoneDrug
Also called Relafen® 750 mg Tablets
Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
RelafenDrug
Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
| Study group | Role | What they receive |
|---|---|---|
| Nabumetone | Experimental | Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited Receives: Drug: Nabumetone |
| Relafen | Active comparator | Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. Receives: Drug: Relafen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence study is based on Cmax and AUC parameters
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2006
- Study completionMar 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Mohan lal Siva Prasad Sayana, Principal investigator, Bioserve Clinical Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164826
- Sponsor's protocol ID
- P-605/06-00
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's and Relafen® 750 mg Tablets of Glaxosmithkline, in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01164826
- Acronym / sponsor ID
- P-605/06-00
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Nabumetone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 19 Jul 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.
The purpose of this study is:
- To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fed conditions with a washout period of 16 days.
- To monitor adverse events and ensure the safety of subjects.
Detailed description
A randomized, open label, two treatment, two period, two sequence, single dose crossover, bioequivalence study of nabumetone 750 mg tablets of Dr. Reddy's Laboratories Limited and Relafen® 750 mg tablets of Glaxosmithkline research triangle park, in healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabumetone | Experimental | Drug: NabumetoneNabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited |
| Relafen | Active comparator | Drug: RelafenRelafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- Subjects who will provide written informed consent
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- Subjects must be of normal health, as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
Key exclusion criteria (26 listed)
- Subjects incapable of understanding the informed consent.
- Subjects who have:
- History of hypersensitivity or idiosyncratic reaction to Nabumetone or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Clinically significant illness within 4 weeks before the start of the study.
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 |
|---|---|---|
| NabumetoneAlso: Relafen® 750 mg TabletsNabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited | Drug | Nabumetone |
| RelafenRelafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. | Drug | Relafen |
Primary outcome
Bioequivalence study is based on Cmax and AUC parameters
Time frame: 1 month
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 19 Jul 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. Mohan lal Siva Prasad Sayana principal investigator
Bioserve Clinical Research Private Limited
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 Nabumetone and Relafen 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 8 inclusion and 26 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 19 Jul 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 study is based on Cmax and AUC parameters (time frame: 1 month). 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 19 Jul 2010.