Bioequivalence of phenazopyridine HCl in healthy volunteers
| ISRCTN | ISRCTN24855722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24855722 |
| Secondary identifying numbers | URG/STEROP/001 |
- Submission date
- 28/08/2008
- Registration date
- 23/10/2008
- Last edited
- 23/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Waqar H Kazmi
Scientific
Scientific
Office of the Principal
Karachi Medical and Dental College
Karachi
-
Pakistan
Study information
| Study design | Randomised, single-blind, cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Two-treatment, two-period, randomised, single-blind, cross-over bioequivalence of phenazopyridine HCl in 24 healthy volunteers |
| Study objectives | The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product. This is necessary to demonstrate bioequivalence to regulatory authorities. |
| Ethics approval(s) | IEC/IRB of the City Medical Committee, Karachi, Pakistan. Date of approval: 02/07/2008 (ref: ERB/HC/002) |
| Health condition(s) or problem(s) studied | Local analgesic for the urinary tract |
| Intervention | 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 phenazopyridine (one tablet x 100 mg) as reference product Pyridium® (Pfizer, USA). Both drugs will be administered orally in fasting state. All participants will be given each of the two drugs only once, in a cross-over design. The duration of washout period is 7 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Phenazopyridine HCl |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 04/08/2008 |
| Completion date | 04/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/08/2008 |
| Date of final enrolment | 04/11/2008 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Office of the Principal
Karachi
-
Pakistan
-
Pakistan
Sponsor information
Phoenix International (UAE)
Industry
Industry
PO Box 64613
Dubai
-
United Arab Emirates
Funders
Funder type
Not defined
Phoenix International (UAE)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
