HealthyPhase 1NCT00992238
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
A Phase 1 study testing Flavoxate Hydrochloride Tablets, 100mg and Urispas® Tablets, 100mg in people with Healthy, run by Padagis LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flavoxate Hydrochloride Tablets, 100mg and Urispas® Tablets, 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Who cannot join
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Flavoxate hydrochloride or related drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.
- Conditions
- Healthy
- Being tested
- Flavoxate Hydrochloride Tablets, 100mg, Urispas® Tablets, 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavoxate Hydrochloride Tablets, 100mgDrug
Urispas® Tablets, 100mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Flavoxate Hydrochloride Tablets, 100mg | Experimental | Not described Receives: Drug: Flavoxate Hydrochloride Tablets, 100mg |
| Urispas® Tablets, 100mg | Active comparator | Not described Receives: Drug: Urispas® Tablets, 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence according to US FDA guidelines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlson, Pharm.D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992238
- Sponsor's protocol ID
- R03155
- Status last verified
- Jul 2023
- First submitted
- 7 Oct 2009
- Last updated
- 10 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00992238
- Acronym / sponsor ID
- R03155
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- First posted
- 9 Oct 2009 (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 purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavoxate Hydrochloride Tablets, 100mg | Experimental | Drug: Flavoxate Hydrochloride Tablets, 100mg |
| Urispas® Tablets, 100mg | Active comparator | Drug: Urispas® Tablets, 100mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Key exclusion criteria (2 listed)
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Flavoxate hydrochloride or related drugs
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 |
|---|---|---|
| Flavoxate Hydrochloride Tablets, 100mg | Drug | Flavoxate Hydrochloride Tablets, 100mg |
| Urispas® Tablets, 100mg | Drug | Urispas® Tablets, 100mg |
Primary outcome
Bioequivalence according to US FDA guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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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.
Carlson, Pharm.D. principal investigator
PRACS Institute, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flavoxate Hydrochloride Tablets, 100mg and Urispas® Tablets, 100mg in people with Healthy, run by Padagis LLC at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jul 2023. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bioequivalence according to US FDA guidelines. 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 10 Jul 2023.