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Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions

This study has been completed.
Information provided by:
Dr. Reddy's Laboratories Limited Identifier:
First received: January 8, 2010
Last updated: January 19, 2010
Last verified: January 2010
An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.

Condition Intervention Phase
Drug: Naproxen Sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]

Enrollment: 26
Study Start Date: May 2006
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naproxen Sodium 550 mg Tablets
Naproxen Sodium 550 mg Tablets of Dr. Reddy's Laboratories Limited
Drug: Naproxen Sodium
Naproxen Sodium Tablets 550 mg
Other Name: Anaprox DS 550 mg
Active Comparator: Anaprox DS 550mg Tablets
Anaprox DS 550mg Tablets of Roche Pharmaceuticals Inc
Drug: Naproxen Sodium
Naproxen Sodium Tablets 550 mg
Other Name: Anaprox DS 550 mg

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
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Please refer to this study by its identifier: NCT01052792

Wellquest Clinical Research
Mumbai, Maharashtra, India, 400 013
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Dr. Umesh Dhakate, MBBS Wellquest Clinical Research
  More Information

Responsible Party: Vice President - Research & Development, Dr. Reddy's Laboratories Limited Identifier: NCT01052792     History of Changes
Other Study ID Numbers: CR-BE-138-NAPR-2005
Study First Received: January 8, 2010
Last Updated: January 19, 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017