Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01164813
First received: July 16, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 fasting conditions with a washout period of 14 days.
  • To monitor adverse events and ensure the safety of subjects.

Condition Intervention Phase
Healthy
Drug: Nabumetone
Drug: Relafen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence study is based on Cmax and AUC parameters [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2006
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nabumetone
Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
Drug: Nabumetone
Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
Other Name: Relafen® 750 mg Tablets
Active Comparator: Relafen
Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
Drug: Relafen
Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.

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 fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

The subjects will be excluded based on the following criteria:

  • Subjects incapable of understanding the informed consent.
  • Subjects who have:

    1. Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg
    2. 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.
    3. Pulse rate below SO/min and above lOO/min.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164813

Locations
India
Bioserve Clinical Research Pvt. Ltd.
Hyderabad, Andhra Pradesh, India, 500037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Mohan lal Siva Prasad Sayana Bioserve Clinical Research Private Limited
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan/ Vice President - R & D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01164813     History of Changes
Other Study ID Numbers: P-604/06-00
Study First Received: July 16, 2010
Last Updated: July 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Nabumetone

Additional relevant MeSH terms:
Nabumetone
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014