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Bioequivalence of Phenazopyridine HCl in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00743977
Recruitment Status : Unknown
Verified August 2008 by Universal Enterprises.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2008
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product.

Condition or disease Intervention/treatment
Human Volunteers Drug: Phenazopyridine HCl

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 2 Treatment, 2 Period, Randomized, Single Blinded, Crossover Bioequivalence of Phenazopyridine HCl in 24 Healthy Volunteers
Study Start Date : August 2008
Estimated Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A Drug: Phenazopyridine HCl
100mg tablet in fasting state
Other Name: Pyridium
Experimental: B Drug: Phenazopyridine HCl
100mg tablet in fasting state
Other Name: Pyridium


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

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): NCT00743977


Locations
Pakistan
Health Care Hospital
Karachi, Pakistan
Sponsors and Collaborators
Universal Enterprises
Investigators
Principal Investigator: Waqar H. Kazmi, M.D, M.S.
More Information

Responsible Party: Head of Clinical Research, Universal Research Group
ClinicalTrials.gov Identifier: NCT00743977     History of Changes
Other Study ID Numbers: URG/STEROP/001
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008