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Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01052792
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 20, 2010
Last Update Posted Date January 20, 2010
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
Official Title  ICMJE 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
Brief Summary An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Naproxen Sodium
Naproxen Sodium Tablets 550 mg
Other Name: Anaprox DS 550 mg
Study Arms  ICMJE
  • Experimental: Naproxen Sodium 550 mg Tablets
    Naproxen Sodium 550 mg Tablets of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Naproxen Sodium
  • Active Comparator: Anaprox DS 550mg Tablets
    Anaprox DS 550mg Tablets of Roche Pharmaceuticals Inc
    Intervention: Drug: Naproxen Sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2010)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01052792
Other Study ID Numbers  ICMJE CR-BE-138-NAPR-2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vice President - Research & Development, Dr. Reddy's Laboratories Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Umesh Dhakate, MBBS Wellquest Clinical Research
PRS Account Dr. Reddy's Laboratories Limited
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP