Bioequivalence of Phenazopyridine HCl in Healthy Volunteers

August 28, 2008 updated by: Universal Enterprises

2 Treatment, 2 Period, Randomized, Single Blinded, Crossover Bioequivalence of Phenazopyridine HCl in 24 Healthy Volunteers

The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

  • Pakistan
      • Karachi, Pakistan
        • Health Care Hospital

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 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects aged 18 to 55 (Male & Female)
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests
  • Informed consent signed by the subject
  • The subject is co-operative and available for the entire study
  • Not pregnant or nursing
  • Normal renal and hepatic function

Exclusion Criteria:

  • Evidence in the subject medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation
  • Hypersensitivity to subject drug, atopic eczema or allergic bronchial asthma
  • Evidence of hypertension (blood pressure after 3 minutes sitting>160/95 mm Hg)
  • Evidence of chronic or acute infectious diseases;
  • History or evidence of malignant tumors;
  • Evidence of hyperuricaemia, elevated serum uric acid (>8.0 mg/dl)
  • Hepatic or renal impairment; elevated serum creatinine (>1.4 mg/dl)
  • Planned vaccination during the time course of the study
  • Adherence to a diet (i.e, vegetarian) or life style (incl. extreme sports) that might interfere with the investigation
  • Laboratory test results outside the tolerance values as laid down by the study centre, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody or HBs antigen testing
  • Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription)
  • Single use of any medication (including OTC) that are not expressively permitted within two weeks prior to start of the study
  • Abuse of alcohol, caffeine or tobacco (equivalent to more than 10 cigarettes a day)
  • Drug addiction
  • Participation in a clinical investigation or blood donation of more than 250 ml within the past eight weeks or blood donation of less than 250 ml within the past 4 week

  • Subjects who are known or suspected

    • not to comply with the study directives
    • not to be reliable or trustworthy
    • not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent),in particular regarding the risks and discomfort to which they would agree to be exposed.
    • to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Phenazopyridine HCl
100mg tablet in fasting state
Other Names:
  • Pyridium
Experimental: B
Drug: Phenazopyridine HCl
100mg tablet in fasting state
Other Names:
  • Pyridium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome of the study will be to determine the bioequivalence of both the formulations of phenazopyridine
Time Frame: regular intervals after drug dosing
regular intervals after drug dosing

Collaborators and Investigators

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

Sponsor

Universal Enterprises

Investigators

  • Principal Investigator: Waqar H. Kazmi, M.D, M.S.

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

August 1, 2008

Primary Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2008

Last Update Submitted That Met QC Criteria

August 28, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • URG/STEROP/001

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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