Local analgesic for the urinary tract Urological and Genital Diseases
Conditions
Interventions
To demonstrate the bioequivalence of a generic product containing phenazopyridine (one tablet x 100 mg) as test product Uropyrine® (Sterop Laboratories, Belgium) with the original formulation of phena
Sponsors
Phoenix International (UAE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18 to 55 (male and female) 2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests 3. Informed consent signed by the subject 4. The subject is co-operative and available for the entire study 5. Not pregnant or nursing 6. Normal renal and hepatic function
Exclusion criteria
Exclusion criteria: 1. Evidence in the subject medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological 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 2. Hypersensitivity to subject drug, atopic eczema or allergic bronchial asthma 3. Evidence of hypertension (blood pressure after 3 minutes sitting >160/95 mmHg) 4. Evidence of chronic or acute infectious diseases 5. History or evidence of malignant tumours 6. Evidence of hyperuricaemia, elevated serum uric acid (>8.0 mg/dl) 7. Hepatic or renal impairment; elevated serum creatinine (>1.4 mg/dl) 8. Planned vaccination during the time course of the study 9. Adherence to a diet (e.g., vegetarian) or life style (including extreme sports) that might interfere with the investigation 10. 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, Hepatitis C virus (HCV) antibody or Hepatitis B (HBs) antigen testing 11. Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription) 12. Single use of any medication (including over-the-counter medication) that are not expressively permitted within two weeks prior to start of the study 13. Abuse of alcohol, caffeine or tobacco (equivalent to more than 10 cigarettes a day) 14. Drug addiction 15. 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 weeks 16. Subjects who are known or suspected: 16.1. not to comply with the study directives 16.2. not to be reliable or trustworthy 16.3. 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 16.4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the bioequivalence of both formulations of phenazopyridine, as determined by the following (monitored for 24 hours after administration of drug): 1. Measurement of the pharmacokinetic parameters 2. Maximum serum concentration (Cmax) 3. Time to maximum serum concentration (tmax) 4. Area under the curve (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of each of the two product regimens, monitored at 4, 10 and 24 hours. Follow up will be carried out after 7 days. | — |
Countries
Pakistan
Outcome results
None listed