Human VolunteersNCT00743977
Bioequivalence of Phenazopyridine HCl in Healthy Volunteers
A study testing Phenazopyridine HCl in people with Human Volunteers, run by Universal Enterprises at 1 site in Pakistan.
Trial summary
The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- Phenazopyridine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2 Treatment, 2 Period, Randomized, Single Blinded, Crossover Bioequivalence of Phenazopyridine HCl in 24 Healthy Volunteers
The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product.
- Conditions
- Human Volunteers
- Being tested
- Phenazopyridine HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenazopyridine HClDrug
Also called Pyridium
100mg tablet in fasting state
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Phenazopyridine HCl |
| B | Experimental | Not described Receives: Drug: Phenazopyridine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study will be to determine the bioequivalence of both the formulations of phenazopyridine
Measured: regular intervals after drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Enterprises
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Waqar H. Kazmi, M.D, M.S., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743977
- Sponsor's protocol ID
- URG/STEROP/001
- Status last verified
- Aug 2008
- First submitted
- 28 Aug 2008
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Treatment, 2 Period, Randomized, Single Blinded, Crossover Bioequivalence of Phenazopyridine HCl in 24 Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00743977
- Acronym / sponsor ID
- URG/STEROP/001
- Conditions
- Human Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universal EnterprisesIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (estimated)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Phenazopyridine HCl |
| B | Experimental | Drug: Phenazopyridine HCl |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenazopyridine HClAlso: Pyridium100mg tablet in fasting state | Drug | A, B |
Primary outcome
The primary outcome of the study will be to determine the bioequivalence of both the formulations of phenazopyridine
Time frame: regular intervals after drug dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqar H. Kazmi, M.D, M.S. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenazopyridine HCl in people with Human Volunteers, run by Universal Enterprises at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of the study will be to determine the bioequivalence of both the formulations of phenazopyridine (time frame: regular intervals after drug dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2008.