Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions

Condition(s) targeted: Healthy

Intervention: Ibuprofen + Pseudoephedrine Hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Vijayanthi G, MBBS, MD, Principal Investigator, Affiliation: Lotus Labs Pvt. Ltd.

The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.

Official title: A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fed 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: This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fed conditions with a washout period of 7 days.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy human subjects between 18-50 years of age (inclusive), weighing as per the

standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. & Max. Chart)

- Subjects who have no evidence of underlying disease during screening medical history

and whose physical examination is performed within 21 days to commencement of the study.

- Subjects whose screening laboratory values are within normal limits or considered by

the physician/Principal Investigator to be of no clinical significance.

- Informed consent given in written form according to section 10. 3 of the protocol.

- Female Subjects:

1. of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. 2. postmenopausal for at least 1 year. 3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject. Exclusion Criteria: 1. History or presence of significant: i. 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 on assumption of tobacco

products.

- History of difficulty in swallowing.

- Clinically significant illness within 4 weeks before the start of the study

- Asthma, urticaria or other allergic type reactions after taking any medication.

2. Subjects who, through completion of the study, would have donated in excess of

- 500 ml of blood in 14 days, or

- 500 - 800 m l 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

3. Participation in another clinical trial within the preceding 28 days of study start. 4. Subjects who have:

- Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg

- Diastolic blood pressure less than 60 m 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.

5. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Lotus Labs Pvt. Ltd., Bangalore, Karnataka 560034, India

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