HealthyNCT00802451
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
A study testing Mesalamine in people with Healthy, run by Padagis LLC.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Mar 2003
- 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 men or women, 18 to 55 years of age
- weight within +/- 25% for height and weight for body frame
- willing to participate and sign a copy of the informed consent form
Who cannot join
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to mesalamine
- evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- receipt of any drugs as part of a research study within 28 days prior to study dosing
About this study
Official title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.
- Conditions
- Healthy
- Being tested
- Mesalamine
- Keywords
- Bioavailability, Mesalamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Active comparator | Not described Receives: Drug: Mesalamine |
| Reference Drug | Active comparator | Not described Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startFeb 2003
- Primary completionMar 2003
- Study completionMar 2003
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802451
- Sponsor's protocol ID
- 10216928
- Status last verified
- Oct 2021
- First submitted
- 4 Dec 2008
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
- ClinicalTrials.gov ID
- NCT00802451
- Acronym / sponsor ID
- 10216928
- Conditions
- Healthy
- Keywords
- Bioavailability, Mesalamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 5 Dec 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 purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Active comparator | Drug: Mesalamine |
| Reference Drug | Active comparator | Drug: Mesalamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men or women, 18 to 55 years of age
- weight within +/- 25% for height and weight for body frame
- willing to participate and sign a copy of the informed consent form
Key exclusion criteria (5 listed)
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to mesalamine
- evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- receipt of any drugs as part of a research study within 28 days prior to study dosing
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 |
|---|---|---|
| Mesalamine | Drug | Reference Drug, Test Drug |
Primary outcome
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
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 15 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mesalamine in people with Healthy, run by Padagis LLC.
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 3 inclusion and 5 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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 was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity. 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 15 Oct 2021.