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

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Naproxen Sodium & Pseudoephedrine HCl (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Sandhya Ravi, MBBS, MS., Principal Investigator, Affiliation: Lotus Labs Pvt. Ltd.,

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 fasting conditions.

Clinical Details

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 Fasting Conditions.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on Cmax and AUC parameters

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Lotus Labs Private Limited, Bangalore, Karnataka 560034, India
Additional Information

Starting date: July 2004
Last updated: June 11, 2010

Page last updated: August 23, 2015

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