Condition category
Urological and Genital Diseases
Date applied
28/08/2008
Date assigned
23/10/2008
Last edited
23/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Waqar H Kazmi

ORCID ID

Contact details

Office of the Principal
Karachi Medical and Dental College
Karachi
-
Pakistan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

URG/STEROP/001

Study information

Scientific title

Two-treatment, two-period, randomised, single-blind, cross-over bioequivalence of phenazopyridine HCl in 24 healthy volunteers

Acronym

Study hypothesis

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

IEC/IRB of the City Medical Committee, Karachi, Pakistan. Date of approval: 02/07/2008 (ref: ERB/HC/002)

Study design

Randomised, single-blind, cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Phenazopyridine HCl

Primary outcome measures

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 trial start date

04/08/2008

Overall trial end date

04/11/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

04/08/2008

Recruitment end date

04/11/2008

Locations

Countries of recruitment

Pakistan

Trial participating centre

Office of the Principal
Karachi
-
Pakistan

Sponsor information

Organisation

Phoenix International (UAE)

Sponsor details

PO Box 64613
Dubai
-
United Arab Emirates

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Phoenix International (UAE)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes