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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ibuprofen + Pseudoephedrine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen + Psuedoephedrine Hydrochloride; Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets	Drug: Ibuprofen + Pseudoephedrine Hydrochloride; Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets; Other Names: Advil® Cold and Sinus
Active Comparator: Advil® Cold and Sinus; Advil® Cold and Sinus Tablets of Wyeth Consumer Healthcare	Drug: Ibuprofen + Pseudoephedrine Hydrochloride; Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets; Other Names: Advil® Cold and Sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	2 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Vijayanthi G, MBBS, MD, Lotus Labs Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2010
• Last Update Submitted That Met QC Criteria: June 11, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Crossover; Ibuprofen and Pseudoephedrine
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ibuprofen; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: 431-04