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

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ClinicalTrials.gov Identifier: NCT01131780
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : June 14, 2010
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Ibuprofen + Pseudoephedrine Hydrochloride Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : October 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : November 2004


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 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




Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: M.S. Mohan, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01131780     History of Changes
Other Study ID Numbers: 432/04
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 14, 2010
Last Verified: June 2010

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

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