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

NCT ID: NCT01131767

Last Updated: 2010-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-09-30

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Naproxen Sodium & Pseudoephedrine HCl

Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories.

Group Type: EXPERIMENTAL

Naproxen Sodium & Pseudoephedrine HCl

Intervention Type: DRUG

Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets

Aleve Cold and Sinus

Aleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets).

Group Type: ACTIVE_COMPARATOR

Naproxen Sodium & Pseudoephedrine HCl

Intervention Type: DRUG

Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets

Interventions

Naproxen Sodium & Pseudoephedrine HCl

Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets

Intervention Type: DRUG

Other Intervention Names

Aleve Cold and Sinus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Sandhya Ravi, MBBS, MS.

Role: PRINCIPAL_INVESTIGATOR

Lotus Labs Pvt. Ltd.,

Locations

Lotus Labs Private Limited

Bangalore, Karnataka, India

Countries

India

Other Identifiers

398/04

Identifier Type: -

Identifier Source: org_study_id