Bioequivalence of Phenazopyridine HCl in Healthy Volunteers

Universal Enterprises

Status

Unknown

Conditions

Human Volunteers

Treatments

Drug: Phenazopyridine HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00743977

URG/STEROP/001

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.