Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions

June 11, 2010 updated by: Dr. Reddy's Laboratories Limited

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fasting Conditions.

The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fasting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fasting conditions with a washout period of 14 days.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Lotus Labs Private Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be considered for inclusion into this study:

  • Subjects will provide written informed consent.
  • Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
  • Subjects must be within ±15% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non- medical cases.
  • Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
  • Have normal ECG, X-ray and vital signs.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

If subject is a female volunteer and

  • Is 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.
  • Is postmenopausal for at least 1 year.
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

The subjects will be excluded under following conditions:

History or presence of significant:

  • Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
  • Alcohol dependence, alcohol abuse or drug abuse within past one year.
  • Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
  • Asthma, urticaria or other allergic type reactions after taking any medication.

Subjects who through completion of the study, would have donated in excess of

  • 500 ml of blood in 14 days, or
  • 500 - 800ml of blood in 14 days (unless approved by the Principal Investigator)
  • 1000 ml of blood in 90 days
  • 1250 ml of blood in 120 days
  • 1500 ml of blood in 180 days
  • 2000 ml of blood in 270 days
  • 2500 ml of blood in 1 year Subjects who have participated in another clinical trial within 3 months of study start.

Subjects who have:

  • Systolic blood pressure less than 90 mm of Hg and higher than 150 mm of Hg
  • Diastolic blood pressure less than 60 mm of Hg and more than 95 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator.
  • Pulse rate below 50/min. and above 105/min. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Naproxen Sodium & Pseudoephedrine HCl
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories.
Drug: Naproxen Sodium & Pseudoephedrine HCl
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other Names:
  • Aleve Cold and Sinus
ACTIVE_COMPARATOR: Aleve Cold and Sinus
Aleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets).
Drug: Naproxen Sodium & Pseudoephedrine HCl
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other Names:
  • Aleve Cold and Sinus

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Reddy's Laboratories Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

August 1, 2004

Study Completion (ACTUAL)

September 1, 2004

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (ESTIMATE)

May 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2010

Last Update Submitted That Met QC Criteria

June 11, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 391/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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