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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nabumetone; Drug: Relafen

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500037
      • Bioserve Clinical Research Pvt. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence study is based on Cmax and AUC parameters	1 month

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr. Mohan lal Siva Prasad Sayana, Bioserve Clinical Research Private Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Estimate): July 19, 2010
• Last Update Submitted That Met QC Criteria: July 16, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Crossover; Nabumetone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Nabumetone
• Other Study ID Numbers: P-604/06-00