Therapeutic EquivalencyPhase 1NCT01405157
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
A Phase 1 study testing methylprednisolone in people with Therapeutic Equivalency, run by Pfizer.
Trial summary
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 20 Feb 2012
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 21 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs).
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive uring drug screen.
About this study
Official title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
- Conditions
- Therapeutic Equivalency
- Being tested
- methylprednisolone
- Keywords
- bioequivalence study, methylprednisolone, suspension, tablets, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constituted powder for oral suspension 4 mg/mL single dose at 16 mg
tablets 16 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone suspension | Experimental | Not described Receives: Drug: methylprednisolone |
| methylprednisolone tablets | Active comparator | Not described Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf (area under the concentration time curve to infinity)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Cmax (maximum concentration)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary outcomes (3)
AUClast (area under the concentration time curve to last time point)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Tmax (time at maximum concentration)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Half-life
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study start1 Jan 2012 (estimated)
- Primary completion20 Feb 2012 (estimated)
- Study completion20 Feb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405157
- Sponsor's protocol ID
- B0121007
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2011
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01405157
- Acronym / sponsor ID
- B0121007
- Conditions
- Therapeutic Equivalency
- Keywords
- bioequivalence study, methylprednisolone, suspension, tablets, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2012 (estimated)
- Primary completion
- 20 Feb 2012 (estimated)
- Study completion
- 20 Feb 2012 (estimated)
- First posted
- 29 Jul 2011 (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.
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone suspension | Experimental | Drug: methylprednisolone |
| methylprednisolone tablets | Active comparator | Drug: methylprednisolone |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects between the ages of 21 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs).
Key exclusion criteria (2 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive uring drug screen.
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 |
|---|---|---|
| methylprednisoloneconstituted powder for oral suspension 4 mg/mL single dose at 16 mg | Drug | methylprednisolone suspension |
| methylprednisolonetablets 16 mg single dose | Drug | methylprednisolone tablets |
Primary outcome
AUCinf (area under the concentration time curve to infinity)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Cmax (maximum concentration)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
3 secondary outcomes
AUClast (area under the concentration time curve to last time point)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Tmax (time at maximum concentration)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Half-life
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing methylprednisolone in people with Therapeutic Equivalency, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 23 Oct 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
AUCinf (area under the concentration time curve to infinity) (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose). The study lists 2 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 23 Oct 2018.