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

NCT01131767 | Completed Phase 1

• 1 other identifier: 398/04
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Naproxen Sodium and Pseudoephedrine Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Naproxen Sodium & Pseudoephedrine HCl

EXPERIMENTAL

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

Drug: Naproxen Sodium & Pseudoephedrine HCl

Aleve Cold and Sinus

ACTIVE COMPARATOR

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

Drug: Naproxen Sodium & Pseudoephedrine HCl

Interventions

Naproxen Sodium & Pseudoephedrine HCl DRUG

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

Also known as: Aleve Cold and Sinus

Aleve Cold and Sinus; Naproxen Sodium & Pseudoephedrine HCl

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lotus Labs Private Limited

Bangalore, Karnataka, 560034, India

Location

MeSH Terms

Interventions

Naproxen; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Sandhya Ravi, MBBS, MS.

  Lotus Labs Pvt. Ltd.,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: July 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2004
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

IN (1)