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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01131767
• Date of registration: 26/05/2010
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
• Scientific 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.
• Date of first enrolment: July 2004
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01131767
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

India

Contacts

• Name: Sandhya Ravi, MBBS, MS.
• Affiliation: Lotus Labs Pvt. Ltd.,

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Naproxen Sodium & Pseudoephedrine HCl

Primary Outcome(s)

Bioequivalence based on Cmax and AUC parameters [Time Frame: 3 months]

Secondary ID(s)

398/04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors