Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition

January 20, 2010 updated by: Dr. Reddy's Laboratories Limited

Open Label,Balanced,Randomized,Two-treatment,Two-sequence,Two Period,Single-dose,Crossover Oral Bioequivalence Study of Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets of Dr.Reddy's and Advil®PM of Wyeth in Normal,Healthy,Adult,Human Subjects Under Fed Conditions.

To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed Description : The study was conducted as an Open label, balanced, randomized, two-treatment, two-sequence, two period,single-dose, crossover oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil@PM, of Wyeth Consumer Healthcare, USA., in normal, healthy, adult, human subjects under fed conditions. A total number of forty (40) subjects were enrolled in the study and all the subjects completed both the periods of the study.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Hyderabad
      • Amirpet, Hyderabad, India, 500 038
        • GVK Biosciences Pvt. Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy human subjects aged between 18 and 45 years (including both).
  • Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
  • Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
  • Subjects having normal 12 lead electrocardiogram (ECG).
  • Subjects having normal chest X-Ray (P/A view).
  • Subjects able to communicate effectively.
  • Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
  • Female subjects who are postmenopausal or surgically sterile.
  • Female subjects 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.

Exclusion Criteria:

  • Subjects having contraindications or hypersensitivity to Ibuprofen Diphenhydramine citrate or related group of drugs.
  • History or presence of any medical conditions or disease according to the opinion of the physician.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
  • Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  • Pulse rate less than 50 beats/minute or more than 100 beats/minute.
  • Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • Donation of blood in the past 3 months before screening.
  • Female subjects demonstrating a positive pregnancy screen.
  • Female subjects who are currently breast-feeding.
  • Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets of Dr. Reddy's
Drug: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other Names:
  • Advil PM
Active Comparator: Advil
Advil PM 200 mg/38 mg Tablets of Wyeth
Drug: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other Names:
  • Advil PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence study of Dr. Reddys Laboratories Limited, Ibuprofen and Diphenhydramine Citrate Caplets under fasting condition
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Reddy's Laboratories Limited

Investigators

  • Principal Investigator: N. Netaji, MD, GVK Biosciences Pvt. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2010

Last Update Submitted That Met QC Criteria

January 20, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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