Bioequivalence of Phenazopyridine HCl in Healthy Volunteers

NCT00743977 | Unknown DMC

• 1 other identifier: URG/STEROP/001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Volunteers

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study will be to determine the bioequivalence of both the formulations of phenazopyridine

  regular intervals after drug dosing

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Phenazopyridine HCl

B

EXPERIMENTAL

Drug: Phenazopyridine HCl

Interventions

Phenazopyridine HCl DRUG

100mg tablet in fasting state

Also known as: Pyridium

A; B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universal Enterprises: lead

Study Sites (1)

Health Care Hospital

Karachi, Pakistan

Location

MeSH Terms

Interventions

Phenazopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Waqar H. Kazmi, M.D, M.S.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: August 29, 2008

Record last verified: 2008-08

Locations

PA (1)