HealthyPhase 1NCT00840203
Mesalamine 4 gm/60 mL Rectal Enema
A Phase 1 study testing Rowasa® 4 gm/60 mL Rectal Enema and Mesalamine 4 gm/60 mL Rectal Enema in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rowasa® 4 gm/60 mL Rectal Enema and Mesalamine 4 gm/60 mL Rectal Enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jun 2003
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives).
Who cannot join
- If female pregnant, lactating, or likely to become pregnant during the study.
- History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.
- Significant history or current evidence of chronic infections disease, system disorder or organ disorder.
- History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
- Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives).
Show all 14Show fewer
- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Drug or alcohol addiction requiring treatment in the past 12 months.
- Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
- Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test results for drugs of abuse at screening.
- Positive serum pregnancy test at screening.
- Unable or unwilling to tolerate multiple venipunctures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, 15206
About this study
Official title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Rowasa® 4 gm/60 mL Rectal Enema, Mesalamine 4 gm/60 mL Rectal Enema
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rowasa® 4 gm/60 mL Rectal EnemaDrug
1 x 4 gm/60 mL, single-dose
Mesalamine 4 gm/60 mL Rectal EnemaDrug
1 x 4 gm/60 mL, single-dose
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine | Experimental | Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period Receives: Drug: Mesalamine 4 gm/60 mL Rectal Enema |
| Rowasa® | Active comparator | Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period Receives: Drug: Rowasa® 4 gm/60 mL Rectal Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: Blood samples collected over 48 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 48 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 48 hour period
Secondary outcomes (3)
Cmax - Maximum Observed Concentration
Cmax results for N-Acetylmesalamine metabolite
Measured: Blood samples collected over 48 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
AUC0-inf results for N-Acetylmesalamine metabolite
Measured: Blood samples collected over 48 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
AUC0-t results for N-Acetylmesalamine metabolite
Measured: Blood samples collected over 48 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMay 2003
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shirley Ann Kennedy, M.D., Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840203
- Sponsor's protocol ID
- 10336014
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2009
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. 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
- NCT00840203
- Acronym / sponsor ID
- 10336014
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Posted 4 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalamine | Experimental | Drug: Mesalamine 4 gm/60 mL Rectal EnemaMesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period |
| Rowasa® | Active comparator | Drug: Rowasa® 4 gm/60 mL Rectal EnemaRowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives).
Key exclusion criteria (14 listed)
- If female pregnant, lactating, or likely to become pregnant during the study.
- History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.
- Significant history or current evidence of chronic infections disease, system disorder or organ disorder.
- History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
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 |
|---|---|---|
| Rowasa® 4 gm/60 mL Rectal Enema1 x 4 gm/60 mL, single-dose | Drug | Rowasa® |
| Mesalamine 4 gm/60 mL Rectal Enema1 x 4 gm/60 mL, single-dose | Drug | Mesalamine |
Primary outcome
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-t
3 secondary outcomes
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 48 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 48 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 48 hour period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shirley Ann Kennedy, M.D. principal investigator
Novum Pharmaceutical Research Services
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 Rowasa® 4 gm/60 mL Rectal Enema and Mesalamine 4 gm/60 mL Rectal Enema in people with Healthy, run by Teva Pharmaceuticals USA 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 4 inclusion and 14 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 19 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 48 hour period). The study lists 3 primary outcomes in all. 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 19 Aug 2024.