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

NCT01164826 | Completed Phase 1 DMC

• 1 other identifier: P-605/06-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Nabumetone

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study is based on Cmax and AUC parameters

  1 month

Study Arms (2)

Nabumetone

EXPERIMENTAL

Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited

Drug: Nabumetone

Relafen

ACTIVE COMPARATOR

Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.

Drug: Relafen

Interventions

Nabumetone DRUG

Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited

Also known as: Relafen® 750 mg Tablets

Nabumetone

Relafen DRUG

Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.

Relafen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Pvt. Ltd.

Hyderabad, Andhra Pradesh, 500037, India

Location

MeSH Terms

Interventions

Nabumetone

Intervention Hierarchy (Ancestors)

Butanones; Ketones; Organic Chemicals

Study Officials

• Dr. Mohan lal Siva Prasad Sayana

  Bioserve Clinical Research Private Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: March 1, 2006
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

IN (1)