Overview

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
Summary
An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Naproxen
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.