Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions

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

An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Naproxen Sodium

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: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 013
      • Wellquest Clinical Research

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:

• 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.

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: 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 Names: 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 Names: Anaprox DS 550 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	3 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr. Umesh Dhakate, MBBS, Wellquest Clinical Research

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; crossover; Naproxen
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; 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; Gout Suppressants; Naproxen
• Other Study ID Numbers: CR-BE-138-NAPR-2005