Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition

• ClinicalTrials.gov Identifier: NCT01052129
• Recruitment Status: Completed
• First Posted: January 20, 2010
• Last Update Posted: May 27, 2010
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by: Dr. Reddy's Laboratories Limited

Tracking Information

• First Submitted Date: January 8, 2010
• First Posted Date: January 20, 2010
• Last Update Posted Date: May 27, 2010
• Study Start Date: May 2006
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 19, 2010): Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
• 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 Fasting 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® OS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche Laboratories Inc. 340 Kingsland Street, Newjersy; in healthy,adult, human subjects under fasting conditions with a wash out period of 10 days between two periods.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

Drug: Naproxen sodium

Naproxen Sodium Tablets 550 mg

Other Name: Anaprox

Study Arms

• 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 550 mg Tablets
  Anaprox DS 550 mg Tablets of Roche Pharmaceuticals Inc
  Intervention: Drug: Naproxen sodium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 19, 2010): 26
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2006
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 kglm2, with 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 Omeprazole 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01052129
• Other Study ID Numbers: BE-137-NAPR-2005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vice President - Research & Development, Dr. Reddy's Laboratories Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Dr. Reddy's Laboratories Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dr. Umesh Dhakate, MBBS; Wellquest Clinical Research

• PRS Account: Dr. Reddy's Laboratories Limited
• Verification Date: May 2010