Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01131780
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Ibuprofen + Pseudoephedrine Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2004
Study Completion Date: November 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Advil® Cold and Sinus

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 fasting conditions with a washout period of 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

    • 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:

    • 500ml 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131780

Locations
India
Lotus Labs Pvt. Ltd.
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Vijayanthi G, MBBS, MD Lotus Labs Pvt. Ltd.
  More Information

No publications provided

Responsible Party: M.S. Mohan, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01131780     History of Changes
Other Study ID Numbers: 432/04
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Ibuprofen and Pseudoephedrine

Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Ibuprofen
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014