Bioequivalence of phenazopyridine HCl in healthy volunteers

Completed

• Conditions: ocal analgesic for the urinary tract; Urological and Genital Diseases

• Registration Number: ISRCTN24855722
• Lead Sponsor: Phoenix International (UAE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified