Ulcerative ColitisPhase 1NCT03327558
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
A Phase 1 study testing Apriso 0.375G ER CAP and APRISO 375 mg extended-release capsules in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate and compare the bioavailability of mesalamine Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Apriso 0.375G ER CAP and APRISO 375 mg extended-release capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 18 Aug 2017
- 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
- Healthy male or female, at least 18 years of age
- Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests
Who cannot join
- Any contraindication to mesalamine according to the applicable labeling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Read the detailed description
The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.
- Conditions
- Ulcerative Colitis
- Being tested
- Apriso 0.375G ER CAP, APRISO 375 mg extended-release capsules
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apriso 0.375G ER CAPDrug
ER capsule
APRISO 375 mg extended-release capsulesDrug
375 mg extended-release capsules
| Study group | Role | What they receive |
|---|---|---|
| Apriso 0.375G ER CAP | Experimental | Apriso 0.375G ER Cap Receives: Drug: Apriso 0.375G ER CAP |
| APRISO 375 mg extended-release capsules | Active comparator | APRISO 375 mg ER cap Receives: Drug: APRISO 375 mg extended-release capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum observed plasma concentration)
Maximum observed plasma concentration levels used for descriptive analysis
Measured: 3 hours after oral dose is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start15 May 2017
- Primary completion23 Jun 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327558
- Sponsor's protocol ID
- VLU-P6-774
- Status last verified
- May 2018
- First submitted
- 26 Oct 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03327558
- Acronym / sponsor ID
- VLU-P6-774
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 31 Oct 2017 (actual)
- 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 objective of this study is to evaluate and compare the bioavailability of mesalamine
Detailed description
The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Apriso 0.375G ER CAP | Experimental | Drug: Apriso 0.375G ER CAPApriso 0.375G ER Cap |
| APRISO 375 mg extended-release capsules | Active comparator | Drug: APRISO 375 mg extended-release capsulesAPRISO 375 mg ER cap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female, at least 18 years of age
- Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests
Key exclusion criteria (1 listed)
- Any contraindication to mesalamine according to the applicable labeling
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 |
|---|---|---|
| Apriso 0.375G ER CAPER capsule | Drug | Apriso 0.375G ER CAP |
| APRISO 375 mg extended-release capsules375 mg extended-release capsules | Drug | APRISO 375 mg extended-release capsules |
Primary outcome
Cmax (Maximum observed plasma concentration)
Time frame: 3 hours after oral dose is taken
Maximum observed plasma concentration levels used for descriptive analysis
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 8 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Apriso 0.375G ER CAP and APRISO 375 mg extended-release capsules in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. 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 3 inclusion and 1 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 8 May 2018. 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?
Cmax (Maximum observed plasma concentration) (time frame: 3 hours after oral dose is taken). 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 8 May 2018.