InflammationPhase 1NCT00858195
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
A Phase 1 study testing Indomethacin 75mg Extended-Release Capsules, Sandoz and Indocin 75mg SR Capsules in people with Inflammation, run by Sandoz.
Trial summary
The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Indomethacin 75mg Extended-Release Capsules, Sandoz and Indocin 75mg SR Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jul 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening
Who cannot join
- Positive test results for HIV or hepatitis B or C
- No allergies to indomethacin or related drugs
About this study
Official title: A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions
The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.
- Conditions
- Inflammation
- Being tested
- Indomethacin 75mg Extended-Release Capsules, Sandoz, Indocin 75mg SR Capsules
- Keywords
- Anti-inflammatory
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin 75mg Extended-Release Capsules, SandozDrug
Indocin 75mg SR CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Indomethacin 75mg ER Capsules Receives: Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz |
| 2 | Active comparator | Indocin 75mg SR Capsules Receives: Drug: Indocin 75mg SR Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence according to US FDA guidelines.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startJun 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony R Godfrey, Pharm. D., Principal investigator, PRACS Institute, LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858195
- Sponsor's protocol ID
- R06-0547
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00858195
- Acronym / sponsor ID
- R06-0547
- Conditions
- Inflammation
- Keywords
- Anti-inflammatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Mar 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 demonstrate the bioequivalence of Indomethacin ER Capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Indomethacin 75mg Extended-Release Capsules, SandozIndomethacin 75mg ER Capsules |
| 2 | Active comparator | Drug: Indocin 75mg SR CapsulesIndocin 75mg SR Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C
- No allergies to indomethacin 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 |
|---|---|---|
| Indomethacin 75mg Extended-Release Capsules, Sandoz | Drug | 1 |
| Indocin 75mg SR Capsules | Drug | 2 |
Primary outcome
Bioequivalence according to US FDA guidelines.
Time frame: 8 days
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 29 Mar 2017.
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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.
Anthony R Godfrey, Pharm. D. principal investigator
PRACS Institute, LTD.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indomethacin 75mg Extended-Release Capsules, Sandoz and Indocin 75mg SR Capsules in people with Inflammation, run by Sandoz.
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 29 Mar 2017. 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.
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. (time frame: 8 days). 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 Mar 2017.