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

This study has been completed.
Information provided by:
Dr. Reddy's Laboratories Limited Identifier:
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010

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 fed conditions.

Condition Intervention Phase
Drug: Naproxen Sodium & Pseudoephedrine HCl
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 Fed Conditions.

Resource links provided by NLM:

Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2004
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Aleve Cold and Sinus

Detailed Description:

Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fed conditions with a washout period of 27 days.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01131767

Lotus Labs Private Limited
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Sandhya Ravi, MBBS, MS. Lotus Labs Pvt. Ltd.,
  More Information

No publications provided

Responsible Party: M.S. Mohan / Vice President, R&D, Dr. Reddy's Laboratories Limited Identifier: NCT01131767     History of Changes
Other Study ID Numbers: 398/04
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Naproxen Sodium and Pseudoephedrine Hydrochloride

Additional relevant MeSH terms:
Adrenergic Agents
Analgesics, Non-Narcotic
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on February 27, 2015